HealthyPhase 1NCT04716894

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 474121 in the Blood

A Phase 1 study testing BI 474121 and Itraconazole 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

Search all trials

Trial summary

The main objective of this trial is to investigate the effect on the exposure of BI 474121 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R). Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 474121 and Itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteGermany
Study dates: 1 Feb 2021to 1 Apr 2021
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 50 years (inclusive)
BMI of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Who cannot join

Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and assessed 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 assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

Show all 9Show fewer

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
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: Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 474121 in Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Design Study)

Conditions: Healthy
Being tested: BI 474121, Itraconazole

What participants receive

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

BI 474121Drug
BI 474121 oral solution
ItraconazoleDrug
Itraconazole oral solution

Study groups in NCT04716894
Study group	Role	What they receive
Sequence: BI 474121 alone (Reference) - Itraconazole + BI 474121 (Test)	Experimental	Period 1: Reference (R) treatment: Healthy subjects received a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram (mg)/milliliter (mL) formulation) BI 474121 on day 1 of period 1. Period 2: Test (T) treatment: Healthy subjects received a daily dose of 200 milligram (oral solution, 10 mg/mL) Itraconazole for 14 days (days -3 - 11 of period 2) and a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram mg/mL formulation) BI 474121 on day 1 of period 2. BI 474121 administrations in treatment R and treatment T were separated by a wash-out period of at least 10 days. Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 10 hours before the scheduled dosing of BI 474121 or 9 hours before itraconazole administration. Receives: Drug: BI 474121; Drug: Itraconazole

What is being measured

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

Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.
Measured: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2.
Maximum Measured Concentration of BI 474121 in Plasma (Cmax)
Maximum measured concentration of BI 474121 in plasma (Cmax). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.
Measured: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2.

Secondary outcomes (1)

Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.
Measured: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2.

Timeline

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

1 Feb 20211 Apr 2021

First posted20 Jan 2021
Study start1 Feb 2021
Primary completion1 Apr 2021
Study completion1 Apr 2021

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: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04716894
Sponsor's protocol ID: 1411-0010
Other IDs: 2019-003630-16, 2019
Status last verified: Jul 2023
First submitted: 19 Jan 2021
Last updated: 8 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 474121 in Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Design Study)
ClinicalTrials.gov ID: NCT04716894
Acronym / sponsor ID: 1411-0010
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Feb 2021 (actual)
Primary completion: 1 Apr 2021 (actual)
Study completion: 1 Apr 2021 (actual)
First posted: 20 Jan 2021 (actual)
Results: Posted 8 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: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sequence: BI 474121 alone (Reference) - Itraconazole + BI 474121 (Test)	Experimental	Drug: BI 474121, Drug: ItraconazolePeriod 1: Reference (R) treatment: Healthy subjects received a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram (mg)/milliliter (mL) formulation) BI 474121 on day 1 of period 1. Period 2: Test (T) treatment: Healthy subjects received a daily dose of 200 milligram (oral solution, 10 mg/mL) Itraconazole for 14 days (days -3 - 11 of period 2) and a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram mg/mL formulation) BI 474121 on day 1 of period 2. BI 474121 administrations in treatment R and treatment T were separated by a wash-out period of at least 10 days. Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 10 hours before the scheduled dosing of BI 474121 or 9 hours before itraconazole administration.

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 50 years (inclusive)
BMI of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Key exclusion criteria (9 listed)

Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and assessed 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 assessed 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 474121BI 474121 oral solution	Drug	Sequence: BI 474121 alone (Reference) - Itraconazole + BI 474121 (Test)
ItraconazoleItraconazole oral solution	Drug	Sequence: BI 474121 alone (Reference) - Itraconazole + BI 474121 (Test)

Primary outcome

Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2.
Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.
Maximum Measured Concentration of BI 474121 in Plasma (Cmax)
Time frame: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2.
Maximum measured concentration of BI 474121 in plasma (Cmax). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.

1 secondary outcome

Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2.

Results and safety

Results posted to the registry on 8 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
Sequence: BI 474121 Alone (Reference) - Itraconazole + BI 474121 (Test)	14	14

Primary outcome: Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Time frame: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2.. Geometric mean (Standard Deviation). Unit: hours*nanomole/Liter

Measure	Reference (R) Treatment: BI 474121 Alone n = 13	Test (T) Treatment: Itraconazole + BI 474121 n = 12
Value	NA (NA)	NA (NA)

Reference (R) Treatment: BI 474121 Alone vs Test (T) Treatment: Itraconazole + BI 474121: adjusted geometric mean (gMean) ratio(%): 197.77 (90% CI 187.90 to 208.15)

Population analysed: Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of study drug and who provided at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included in the analyses.

Primary outcome: Maximum Measured Concentration of BI 474121 in Plasma (Cmax)

Measure	Reference (R) Treatment: BI 474121 Alone n = 13	Test (T) Treatment: Itraconazole + BI 474121 n = 12
Value	NA (NA)	NA (NA)

Reference (R) Treatment: BI 474121 Alone vs Test (T) Treatment: Itraconazole + BI 474121: adjusted geometric mean (gMean) ratio(%): 143.38 (90% CI 121.92 to 168.60)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: R treatment: first administration of BI 474121 until 7 days thereafter. Up to 7 days. T treatment: Itraconazole alone: first administration of itraconazole until time of BI 474121 administration OR until 3 days after last dose of itraconazole. Up to 6 days. T treatment: Itraconazole + BI 474121: BI 474121 administration in treatment period 2 until 3 days after the last administration of itraconazole OR 7 days after the BI 474121 administration in period 2, whatever is later. Up to 14 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reference (R) Treatment: BI 474121 Alone	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Test (T) Treatment: Itraconazole Alone	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Test (T) Treatment: Itraconazole + BI 474121	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 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/

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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 474121 and Itraconazole 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 4 inclusion and 9 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 8 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 8 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?

Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (time frame: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2.). 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 NCT04716894.

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 8 Mar 2024.