HealthyPhase 1NCT03934203

This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)

A Phase 1 study testing BI 409306 and Moxifloxacin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this trial is to assess the effect of BI 409306 on the QT/QTc interval in healthy male and female volunteers as measured by the QTcF change from baseline compared with placebo. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 409306 and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteGermany
Study dates: 9 May 2019to 6 Sep 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead single Electrocardiogram (ECG) and 12-lead Holter Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 years (incl.)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and local legislation
Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom

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Sexually abstinent
A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
Surgically sterilised (including hysterectomy)
Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

Who cannot join

Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

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Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Thorough QT Study to Evaluate the Effects of BI 409306 as Single Dose on Cardiac Safety Parameters in Healthy Male and Female Subjects. A Randomized, Placebo Controlled, Double-blind, Five-period Crossover Study With (Open-label) Moxifloxacin as Positive Control

Secondary objectives are to show the assay sensitivity of the trial, by reproducing the typical effect of the positive control moxifloxacin on the QT/QTc interval, and to assess the effect of BI 409306 on heart rate.

Conditions: Healthy
Being tested: BI 409306, Moxifloxacin, Placebo matching to BI 409306

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 409306Drug
Film-coated tablet
MoxifloxacinDrug
Also called Avalox®
Film-coated tablet
Placebo matching to BI 409306Drug
Film-coated tablet

Study groups in NCT03934203
Study group	Role	What they receive
H/L/P/P/M treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
H/M/P/P/L treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
H/P/P/M/L treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
L/M/H/P/P treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
L/P/H/M/P treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
L/P/M/H/P treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
M/H/P/L/P treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
M/L/P/H/P treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
M/P/H/P/L treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
P/H/L/M/P treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
P/H/L/P/M treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
P/L/M/P/H treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
P/M/P/L/H treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
P/P/L/H/M treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306
P/P/M/L/H treatment sequence	Experimental	In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2. Receives: Drug: BI 409306; Drug: Moxifloxacin; Drug: Placebo matching to BI 409306

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum
QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in QTcF changes from baseline between 50 mg BI 409306 and placebo takes its maximum.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 50 mg BI 409306 and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum
QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in QTcF changes from baseline between 250 mg BI 409306 and placebo takes its maximum.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 250 mg BI 409306 and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Secondary outcomes (8)

Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum
QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in QTcF changes from baseline between moxifloxacin and placebo takes its maximum.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for moxifloxacin and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in QTcF at 2 Hours After Drug Administration (Assessment of Assay Sensitivity)
QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at 2 hours after drug administration.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for moxifloxacin and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in QTcF at 3 Hours After Drug Administration (Assessment of Assay Sensitivity)
QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at 3 hours after drug administration.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for moxifloxacin and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in QTcF at 4 Hours After Drug Administration (Assessment of Assay Sensitivity)
QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at 4 hours after drug administration.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for moxifloxacin and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum
Change from baseline in heart rate (HR) at each timepoint between 20 minutes to 24 hours after drug administration where the difference of means in heart rate changes from baseline between 50 milligram (mg) BI 409306 and placebo takes its maximum.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 50 mg BI 409306 and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum
Change from baseline in heart rate (HR) at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in heart rate changes from baseline between 250 milligram (mg) BI 409306 and placebo takes its maximum.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 250 mg BI 409306 and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum
Change from baseline in heart rate (HR) at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in heart rate changes from baseline between 50 milligram (mg) BI 409306 and placebo takes its minimum.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 50 mg BI 409306 and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum
Change from baseline in heart rate (HR) at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in heart rate changes from baseline between 250 milligram (mg) BI 409306 and placebo takes its minimum.
A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 250 mg BI 409306 and the 2 placebo periods.
Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Measured: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 20196 Sep 2019

First posted1 May 2019
Study start9 May 2019
Primary completion6 Sep 2019
Study completion6 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03934203
Sponsor's protocol ID: 1289-0038
Other IDs: 2018-001335-44, 2018
Status last verified: Aug 2023
First submitted: 30 Apr 2019
Last updated: 12 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1\. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Thorough QT Study to Evaluate the Effects of BI 409306 as Single Dose on Cardiac Safety Parameters in Healthy Male and Female Subjects. A Randomized, Placebo Controlled, Double-blind, Five-period Crossover Study With (Open-label) Moxifloxacin as Positive Control
ClinicalTrials.gov ID: NCT03934203
Acronym / sponsor ID: 1289-0038
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 9 May 2019 (actual)
Primary completion: 6 Sep 2019 (actual)
Study completion: 6 Sep 2019 (actual)
First posted: 1 May 2019 (actual)
Results: Posted 12 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 15

Arm	Type	Receives
H/L/P/P/M treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
H/M/P/P/L treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
H/P/P/M/L treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
L/M/H/P/P treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
L/P/H/M/P treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
L/P/M/H/P treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
M/H/P/L/P treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
M/L/P/H/P treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
M/P/H/P/L treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
P/H/L/M/P treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
P/H/L/P/M treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
P/L/M/P/H treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
P/M/P/L/H treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
P/P/L/H/M treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
P/P/M/L/H treatment sequence	Experimental	Drug: BI 409306, Drug: Moxifloxacin, Drug: Placebo matching to BI 409306In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead single Electrocardiogram (ECG) and 12-lead Holter Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 years (incl.)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and local legislation
Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:

Key exclusion criteria (11 listed)

Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 409306Film-coated tablet	Drug	H/L/P/P/M treatment sequence, H/M/P/P/L treatment sequence, H/P/P/M/L treatment sequence, L/M/H/P/P treatment sequence, L/P/H/M/P treatment sequence, L/P/M/H/P treatment sequence, M/H/P/L/P treatment sequence, M/L/P/H/P treatment sequence, M/P/H/P/L treatment sequence, P/H/L/M/P treatment sequence, P/H/L/P/M treatment sequence, P/L/M/P/H treatment sequence, P/M/P/L/H treatment sequence, P/P/L/H/M treatment sequence, P/P/M/L/H treatment sequence
MoxifloxacinAlso: Avalox®Film-coated tablet	Drug	H/L/P/P/M treatment sequence, H/M/P/P/L treatment sequence, H/P/P/M/L treatment sequence, L/M/H/P/P treatment sequence, L/P/H/M/P treatment sequence, L/P/M/H/P treatment sequence, M/H/P/L/P treatment sequence, M/L/P/H/P treatment sequence, M/P/H/P/L treatment sequence, P/H/L/M/P treatment sequence, P/H/L/P/M treatment sequence, P/L/M/P/H treatment sequence, P/M/P/L/H treatment sequence, P/P/L/H/M treatment sequence, P/P/M/L/H treatment sequence
Placebo matching to BI 409306Film-coated tablet	Drug	H/L/P/P/M treatment sequence, H/M/P/P/L treatment sequence, H/P/P/M/L treatment sequence, L/M/H/P/P treatment sequence, L/P/H/M/P treatment sequence, L/P/M/H/P treatment sequence, M/H/P/L/P treatment sequence, M/L/P/H/P treatment sequence, M/P/H/P/L treatment sequence, P/H/L/M/P treatment sequence, P/H/L/P/M treatment sequence, P/L/M/P/H treatment sequence, P/M/P/L/H treatment sequence, P/P/L/H/M treatment sequence, P/P/M/L/H treatment sequence

Primary outcome

Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in QTcF changes from baseline between 50 mg BI 409306 and placebo takes its maximum. A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 50 mg BI 409306 and the 2 placebo periods. Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in QTcF changes from baseline between 250 mg BI 409306 and placebo takes its maximum. A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 250 mg BI 409306 and the 2 placebo periods. Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

8 secondary outcomes

Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in QTcF at 2 Hours After Drug Administration (Assessment of Assay Sensitivity)
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in QTcF at 3 Hours After Drug Administration (Assessment of Assay Sensitivity)
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in QTcF at 4 Hours After Drug Administration (Assessment of Assay Sensitivity)
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum
Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Results and safety

Results posted to the registry on 12 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
H/L/P/P/M Treatment Sequence	3	3
H/M/P/P/L Treatment Sequence	3	3
H/P/P/M/L Treatment Sequence	3	2
L/M/H/P/P Treatment Sequence	3	3
L/P/H/M/P Treatment Sequence	4	3
L/P/M/H/P Treatment Sequence	3	3
M/H/P/L/P Treatment Sequence	4	2
M/L/P/H/P Treatment Sequence	3	3
M/P/H/P/L Treatment Sequence	3	3
P/H/L/M/P Treatment Sequence	3	3
P/H/L/P/M Treatment Sequence	3	3
P/L/M/P/H Treatment Sequence	3	3
P/M/P/L/H Treatment Sequence	3	3
P/P/L/H/M Treatment Sequence	3	2
P/P/M/L/H Treatment Sequence	3	3

Primary outcome: Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum

Time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration. Least squares mean (Standard Error). Unit: milliseconds

Measure	Placebo to BI 409306 in 2 Periods n = 47	50 Milligram (mg) BI 409306 n = 45
20 min after drug intake=timepoint of maximum	-1.5 (0.4)	-0.2 (0.6)
40 minutes after drug intake	-1.0 (0.4)	-0.8 (0.6)
1 hour after drug intake	-0.5 (0.4)	0.3 (0.6)
1 hour and 30 minutes after drug intake	-0.1 (0.5)	-0.4 (0.7)
2 hours after drug intake	-0.1 (0.5)	-0.3 (0.7)
2 hours and 30 minutes after drug intake	-2.0 (0.5)	-1.7 (0.7)
3 hours after drug intake	0.4 (0.5)	-0.2 (0.7)
4 hours after drug intake	1.0 (0.6)	0.0 (0.8)

Placebo to BI 409306 in 2 Periods vs 50 Milligram (mg) BI 409306: Difference of adjusted means: 1.3 (90% CI 0.2 to 2.4), Mixed Models Analysis

Population analysed: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

Primary outcome: Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum

Measure	Placebo to BI 409306 in 2 Periods n = 47	250 Milligram (mg) BI 409306 n = 46
20 minutes after drug intake	-1.4 (0.5)	2.5 (0.6)
40 minutes after drug intake= timepoint of maximum	-1.0 (0.5)	4.7 (0.7)
1 hour after drug intake	-0.4 (0.5)	3.3 (0.7)
1 hour and 30 minutes after drug intake	-0.0 (0.5)	2.7 (0.7)
2 hours after drug intake	-0.1 (0.5)	1.7 (0.7)
2 hours and 30 minutes after drug intake	-1.9 (0.6)	-0.7 (0.8)
3 hours after drug intake	0.4 (0.5)	1.3 (0.7)
4 hours after drug intake	1.0 (0.5)	1.6 (0.8)

Placebo to BI 409306 in 2 Periods vs 250 Milligram (mg) BI 409306: Difference of adjusted means: 5.7 (90% CI 4.4 to 7.1), Mixed Models Analysis

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo 1 to BI 409306	0 of 45 (0%)	2 of 45 (4.4%)	0 of 45
Placebo 2 to BI 409306	0 of 46 (0%)	3 of 46 (6.5%)	0 of 46
50 Milligram (mg) BI 409306	0 of 45 (0%)	12 of 45 (26.7%)	0 of 45
250 Milligram (mg) BI 409306	0 of 46 (0%)	36 of 46 (78.3%)	0 of 46
400 Milligram (mg) Moxifloxacin	0 of 45 (0%)	3 of 45 (6.7%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 409306 and Moxifloxacin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum (time frame: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03934203.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.