HealthyPhase 1NCT04194645

A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink.

A Phase 1 study testing BI 474121 tablet and BI 474121 oral solution 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 main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 474121 tablet and BI 474121 oral solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteGermany
Study dates: 9 Jan 2020to 25 Mar 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 45 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 (Blood pressure (BP), Pulse rate (PR)), 12- lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 45 years (inclusive)
Body mass index (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 Good Clinical Practice (GCP) and local legislation

Who cannot join

Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (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 50 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 34Show 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
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more than 24 g per day)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial
Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
Inability to comply with the dietary regimen of the trial site
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms or any other relevant ECG finding at screening)
A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Male subjects with WOCBP partner who are unwilling to use a highly effective method of birth control from time point of administration of trial medication until 30 days thereafter.
Highly effective methods of birth control are:
Male subject is sexually abstinent
Male subjects is vasectomised (vasectomy at least 1 year prior to enrolment), plus condom in male subject
Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
Use of progestogen-only hormonal contraception by female partner that inhibits ovulation (only injectables or implants), plus condom in male subject
Use of combined (estrogen and progestogen containing) hormonal contraception by female partner that prevents ovulation (oral, intravaginal or transdermal), plus condom in male subject
Female partner is surgically sterilised (including hysterectomy)
Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L is confirmatory) Sperm donation is not allowed from the time point of drug administration until 30 days thereafter.
ALT (alanine transaminase), AST (aspartate transaminase), or serum creatinine exceed upper limit of normal range at screening, confirmed by a repeat test
Orthostatic hypotension during orthostatic testing at Day -3, that the investigator considers to be of clinical relevance (only applicable for Single-rising dose (SRD) part).
During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection.

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: A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 474121 Administered as Oral Solution and Tablets to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 474121 as Tablet Versus Oral Solution and Tablet With and Without Food (BA Part)

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses.

Conditions: Healthy
Being tested: BI 474121 tablet, Placebo tablet, BI 474121 oral solution, Placebo solution

What participants receive

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

BI 474121 tabletDrug
BI 474121 tablet
Placebo tabletDrug
Placebo tablet
BI 474121 oral solutionDrug
BI 474121 oral solution
Placebo solutionDrug
Placebo solution

Study groups in NCT04194645
Study group	Role	What they receive
SRD: Placebo matching BI 474121 oral solution (OS)	Placebo comparator	This arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position. Receives: Drug: Placebo solution
SRD: Placebo matching BI 474121 tablet (T)	Placebo comparator	This arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position. Receives: Drug: Placebo tablet
SRD: 0.25 milligram (mg) BI 474121 - OS	Experimental	A single dose of 0.25 mg BI 474121 was solved in 0.5 mL of water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position. Receives: Drug: BI 474121 oral solution
SRD: 1 mg BI 474121 - OS	Experimental	A single dose of 1 mg BI 474121 was solved in 2mL of water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position. Receives: Drug: BI 474121 oral solution
SRD: 2.5 mg BI 474121 - T	Experimental	A single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position. Receives: Drug: BI 474121 tablet
SRD: 5 mg BI 474121 - T	Experimental	A single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position. Receives: Drug: BI 474121 tablet
SRD: 10 mg BI 474121 - T	Experimental	A single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position. Receives: Drug: BI 474121 tablet
SRD: 20 mg BI 474121 - T	Experimental	A single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position. Receives: Drug: BI 474121 tablet
SRD: 40 mg BI 474121 - T	Experimental	A single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position. Receives: Drug: BI 474121 tablet
BA: BI 474121 10 mg as: OS fasted (Reference (R)) / T fasted (T2) / T fed (T1)	Experimental	Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (Reference (R)), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (Test 2 (T2)) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (Test 1 (T1)). Between periods was a wash-out period of at least 7 days. Receives: Drug: BI 474121 tablet; Drug: BI 474121 oral solution
BA: BI 474121 10 mg as: R / T1 / T2	Experimental	Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days. Receives: Drug: BI 474121 tablet; Drug: BI 474121 oral solution
BA: BI 474121 10mg as: T2 / R / T1	Experimental	Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1). Between periods was a wash-out period of at least 7 days. Receives: Drug: BI 474121 tablet; Drug: BI 474121 oral solution
BA: BI 474121 10mg as: T2 / T1 / R	Experimental	Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as oral solution solved in 20 mL water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days. Receives: Drug: BI 474121 tablet; Drug: BI 474121 oral solution
BA: BI 474121 10mg: T1 / R / T2	Experimental	Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days. Receives: Drug: BI 474121 tablet; Drug: BI 474121 oral solution
BA: BI 474121 10mg: T1 / T2 / R	Experimental	Participants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2) and in period 3 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days. Receives: Drug: BI 474121 tablet; Drug: BI 474121 oral solution

What is being measured

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

Single Rising Dose (SRD): Percentage of Subjects With Drug-related Adverse Events.
For assessment of safety and tolerability of BI 474121 the percentage of participants with drug-related adverse events (AE) was calculated.
All AEs occurring between first drug intake till 7 days after last drug intake were assigned to the randomised treatment.
Measured: From drug administration until 7 days after drug administration, 7 days.
Bioavailability (BA): 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) was analyzed after single dose administration of BI 474121 as: an oral solution in fasted conditions (reference treatment), an uncoated tablet in fed conditions (treatment 1) and an uncoated tablet in fasted conditions (treatment 2).
The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Measured: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.
BA: Maximum Measured Concentration of BI 474121 in Plasma (Cmax )
Maximum measured concentration of of BI 474121 in plasma (Cmax).
The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Measured: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.

Secondary outcomes (3)

SRD: 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) was analyzed after single dose administration of BI 474121.
The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Measured: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.
SRD: Maximum Measured Concentration of of BI 474121 in Plasma (Cmax).
Maximum measured concentration of of BI 474121 in plasma (Cmax).
The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Measured: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.
BA: 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-∞).
The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Measured: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.

Timeline

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

9 Jan 202025 Mar 2021

First posted11 Dec 2019
Study start9 Jan 2020
Primary completion25 Mar 2021
Study completion25 Mar 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04194645
Sponsor's protocol ID: 1411-0001
Other IDs: 2019-002358-22, 2019
Status last verified: Mar 2024
First submitted: 10 Dec 2019
Last updated: 26 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency

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?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 474121 Administered as Oral Solution and Tablets to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 474121 as Tablet Versus Oral Solution and Tablet With and Without Food (BA Part)
ClinicalTrials.gov ID: NCT04194645
Acronym / sponsor ID: 1411-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 9 Jan 2020 (actual)
Primary completion: 25 Mar 2021 (actual)
Study completion: 25 Mar 2021 (actual)
First posted: 11 Dec 2019 (actual)
Results: Posted 26 Mar 2024

Clinical summary

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

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 15

Arm	Type	Receives
SRD: Placebo matching BI 474121 oral solution (OS)	Placebo comparator	Drug: Placebo solutionThis arm comprises all placebo treated participants of the single rising dose (SRD) part treated with an oral solution (placebo treated participants of the two lowest dose group (DG)s). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo powder for oral solution was administered after an overnight fast together with 240 milliliter (mL) of water to participants who were in a standing position.
SRD: Placebo matching BI 474121 tablet (T)	Placebo comparator	Drug: Placebo tabletThis arm comprises all placebo treated participants of the SRD part treated with a tablet (placebo treated participants of the five upper DGs). Participants receiving placebo were equally distributed across dose groups. A single dose of BI 474121 matching placebo tablet was administered after an overnight fast together with 240 mL of water to subjects who were in a standing position.
SRD: 0.25 milligram (mg) BI 474121 - OS	Experimental	Drug: BI 474121 oral solutionA single dose of 0.25 mg BI 474121 was solved in 0.5 mL of water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
SRD: 1 mg BI 474121 - OS	Experimental	Drug: BI 474121 oral solutionA single dose of 1 mg BI 474121 was solved in 2mL of water and was administered after an overnight fast together with 240 mL of water to participants who were in a standing position.
SRD: 2.5 mg BI 474121 - T	Experimental	Drug: BI 474121 tabletA single dose of 2.5 mg BI 474121 was administered as 1 uncoated 2.5 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
SRD: 5 mg BI 474121 - T	Experimental	Drug: BI 474121 tabletA single dose of 5.0 mg BI 474121 was administered as 2 uncoated 2.5 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
SRD: 10 mg BI 474121 - T	Experimental	Drug: BI 474121 tabletA single dose of 10.0 mg BI 474121 was administered as 1 uncoated 10.0 mg tablet after an overnight fast together with 240 mL of water to participants who were in a standing position.
SRD: 20 mg BI 474121 - T	Experimental	Drug: BI 474121 tabletA single dose of 20.0 mg BI 474121 was administered as 2 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
SRD: 40 mg BI 474121 - T	Experimental	Drug: BI 474121 tabletA single dose of 40.0 mg BI 474121 was administered as 4 uncoated 10.0 mg tablets after an overnight fast together with 240 mL of water to participants who were in a standing position.
BA: BI 474121 10 mg as: OS fasted (Reference (R)) / T fasted (T2) / T fed (T1)	Experimental	Drug: BI 474121 tablet, Drug: BI 474121 oral solutionParticipants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (Reference (R)), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (Test 2 (T2)) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (Test 1 (T1)). Between periods was a wash-out period of at least 7 days.
BA: BI 474121 10 mg as: R / T1 / T2	Experimental	Drug: BI 474121 tablet, Drug: BI 474121 oral solutionParticipants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days.
BA: BI 474121 10mg as: T2 / R / T1	Experimental	Drug: BI 474121 tablet, Drug: BI 474121 oral solutionParticipants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1). Between periods was a wash-out period of at least 7 days.
BA: BI 474121 10mg as: T2 / T1 / R	Experimental	Drug: BI 474121 tablet, Drug: BI 474121 oral solutionParticipants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2), in period 2 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1) and in period 3 as oral solution solved in 20 mL water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days.
BA: BI 474121 10mg: T1 / R / T2	Experimental	Drug: BI 474121 tablet, Drug: BI 474121 oral solutionParticipants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R) and in period 3 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2). Between periods was a wash-out period of at least 7 days.
BA: BI 474121 10mg: T1 / T2 / R	Experimental	Drug: BI 474121 tablet, Drug: BI 474121 oral solutionParticipants received a single dose of 10.0 mg BI 474121 in each period, in period 1 as 1 uncoated tablet in fed conditions after a high-fat / high-caloric breakfast with 240 mL of water (T1), in period 2 as 1 uncoated tablet with 240 mL of water after an overnight fast (T2) and in period 3 as oral solution solved in 20 mL of water with 240 mL of water after an overnight fast (R). Between periods was a wash-out period of at least 7 days.

Who may qualify

Ages: 18 to 45 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 (Blood pressure (BP), Pulse rate (PR)), 12- lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 45 years (inclusive)
Body mass index (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 Good Clinical Practice (GCP) and local legislation

Key exclusion criteria (34 listed)

Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (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 50 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 474121 tabletBI 474121 tablet	Drug	BA: BI 474121 10 mg as: OS fasted (Reference (R)) / T fasted (T2) / T fed (T1), BA: BI 474121 10 mg as: R / T1 / T2, BA: BI 474121 10mg as: T2 / R / T1, BA: BI 474121 10mg as: T2 / T1 / R, BA: BI 474121 10mg: T1 / R / T2, BA: BI 474121 10mg: T1 / T2 / R, SRD: 10 mg BI 474121 - T, SRD: 2.5 mg BI 474121 - T, SRD: 20 mg BI 474121 - T, SRD: 40 mg BI 474121 - T, SRD: 5 mg BI 474121 - T
Placebo tabletPlacebo tablet	Drug	SRD: Placebo matching BI 474121 tablet (T)
BI 474121 oral solutionBI 474121 oral solution	Drug	BA: BI 474121 10 mg as: OS fasted (Reference (R)) / T fasted (T2) / T fed (T1), BA: BI 474121 10 mg as: R / T1 / T2, BA: BI 474121 10mg as: T2 / R / T1, BA: BI 474121 10mg as: T2 / T1 / R, BA: BI 474121 10mg: T1 / R / T2, BA: BI 474121 10mg: T1 / T2 / R, SRD: 0.25 milligram (mg) BI 474121 - OS, SRD: 1 mg BI 474121 - OS
Placebo solutionPlacebo solution	Drug	SRD: Placebo matching BI 474121 oral solution (OS)

Primary outcome

Single Rising Dose (SRD): Percentage of Subjects With Drug-related Adverse Events.
Time frame: From drug administration until 7 days after drug administration, 7 days.
For assessment of safety and tolerability of BI 474121 the percentage of participants with drug-related adverse events (AE) was calculated. All AEs occurring between first drug intake till 7 days after last drug intake were assigned to the randomised treatment.
Bioavailability (BA): 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 (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.
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) was analyzed after single dose administration of BI 474121 as: an oral solution in fasted conditions (reference treatment), an uncoated tablet in fed conditions (treatment 1) and an uncoated tablet in fasted conditions (treatment 2). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
BA: Maximum Measured Concentration of BI 474121 in Plasma (Cmax )
Time frame: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.
Maximum measured concentration of of BI 474121 in plasma (Cmax). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.

3 secondary outcomes

SRD: 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 (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.
SRD: Maximum Measured Concentration of of BI 474121 in Plasma (Cmax).
Time frame: Within 3 hours (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.
BA: 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 (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.

Results and safety

Results posted to the registry on 26 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
SRD: Placebo Matching BI 474121 Oral Solution (OS)	4	4
SRD: Placebo Matching BI 474121 Tablet (T)	9	9
SRD: 0.25 Milligram (mg) BI 474121 - OS	6	6
SRD: 1 mg BI 474121 - OS	6	6
SRD: 2.5 mg BI 474121 - T	6	6
SRD: 5 mg BI 474121 - T	6	6
SRD: 10 mg BI 474121 - T	6	6
SRD: 20 mg BI 474121 - T	5	5
SRD: 40 mg BI 474121 - T	6	6
BA: BI 474121 10 mg as: OS Fasted (Reference (R)) / T Fasted (T2) / T Fed (T1)	2	2
BA: BI 474121 10 mg as: R / T1 / T2	2	2
BA: BI 474121 10mg as: T2 / R / T1	2	2
BA: BI 474121 10mg as: T2 / T1 / R	2	2
BA: BI 474121 10mg: T1 / R / T2	2	2
BA: BI 474121 10mg: T1 / T2 / R	2	2

Primary outcome: Single Rising Dose (SRD): Percentage of Subjects With Drug-related Adverse Events.

Time frame: From drug administration until 7 days after drug administration, 7 days.. Number. Unit: Percentage of participants

Measure	SRD: Placebo Matching BI 474121 Oral Solution (OS) n = 4	SRD: Placebo Matching BI 474121 Tablet (T) n = 9	SRD: 0.25 Milligram (mg) BI 474121 - OS n = 6	SRD: 1 mg BI 474121 - OS n = 6	SRD: 2.5 mg BI 474121 - T n = 6	SRD: 5 mg BI 474121 - T n = 6	SRD: 10 mg BI 474121 - T n = 6	SRD: 20 mg BI 474121 - T n = 5	SRD: 40 mg BI 474121 - T n = 6
Value	0.0	11.1	0.0	0.0	16.7	16.7	0.0	20.0	33.3

Population analysed: Treated set (TS) The TS included all participants who were randomized and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the participant received. The TS was used for safety analyses.

Primary outcome: Bioavailability (BA): 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 (h) before drug administration and 15 minutes (min), 30min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, and 96h after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: Hour times nanomole per litre

Measure	BA: 10 mg BI 474121 - Oral Solution - Fasted (Reference (R)) n = 12	BA: 10 mg BI 474121 - Tablet - Fasted (Test 2 (T2)) n = 12	BA: 10 mg BI 474121 - Tablet - Fed (Test 1 (T1)) n = 11
Value	1180 (42.6)	1150 (51.0)	1300 (37.8)

BA: 10 mg BI 474121 - Oral Solution - Fasted (Reference (R)) vs BA: 10 mg BI 474121 - Tablet - Fasted (Test 2 (T2)): Ratio of geometric mean (T2/R): 97.71 (90% CI 91.45 to 104.40), ANOVA
BA: 10 mg BI 474121 - Tablet - Fasted (Test 2 (T2)) vs BA: 10 mg BI 474121 - Tablet - Fed (Test 1 (T1)): Ratio of geometric mean (T1/T2): 112.88 (90% CI 98.82 to 128.94), ANOVA

Population analysed: Pharmacokinetic parameter analysis set (PKS): The PKS included all participants in the TS who provided at least 1 primary or secondary pharmacokinetic (PK) endpoint that were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS.

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

Measure	BA: 10 mg BI 474121 - Oral Solution - Fasted (Reference (R)) n = 12	BA: 10 mg BI 474121 - Tablet - Fasted (Test 2 (T2)) n = 12	BA: 10 mg BI 474121 - Tablet - Fed (Test 1 (T1)) n = 11
Value	165 (39.6)	79.4 (39.0)	95.3 (22.8)

BA: 10 mg BI 474121 - Oral Solution - Fasted (Reference (R)) vs BA: 10 mg BI 474121 - Tablet - Fasted (Test 2 (T2)): Ratio of geometric mean (T2/R): 48.02 (90% CI 41.86 to 55.09), ANOVA
BA: 10 mg BI 474121 - Tablet - Fasted (Test 2 (T2)) vs BA: 10 mg BI 474121 - Tablet - Fed (Test 1 (T1)): Ratio of geometric mean (T1/T2): 122.80 (90% CI 105.04 to 143.56), ANOVA

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: SRD part: From drug administration until the end of residual effect period, up to 168 hours (7 days). BA part: From drug administration until the end of residual effect period, up to 168 hours (7 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SRD: Placebo Matching BI 474121 Oral Solution (OS)	0 of 4 (0%)	0 of 4 (0%)	0 of 4
SRD: Placebo Matching BI 474121 Tablet (T)	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
SRD: 0.25 Milligram (mg) BI 474121 - OS	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SRD: 1 mg BI 474121 - OS	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
SRD: 2.5 mg BI 474121 - T	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SRD: 5 mg BI 474121 - T	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
SRD: 10 mg BI 474121 - T	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SRD: 20 mg BI 474121 - T	0 of 5 (0%)	1 of 5 (20%)	0 of 5
SRD: 40 mg BI 474121 - T	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BA: 10 mg BI 474121 - Oral Solution - Fasted (Reference (R))	0 of 12 (0%)	3 of 12 (25%)	0 of 12
BA: 10 mg BI 474121 - Tablet - Fasted (Test 2 (T2))	0 of 12 (0%)	3 of 12 (25%)	0 of 12
BA: 10 mg BI 474121 - Tablet - Fed (Test 1 (T1))	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11

Limitations and caveats (from the sponsor): Due to the current COVID-19 pandemic, the recruitment of new subjects was temporarily discontinued. Ongoing, randomised patients were managed as per Trial Protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency

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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 474121 tablet and BI 474121 oral solution 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 34 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 26 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. Some participants in this study may receive a placebo. 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 26 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?

Single Rising Dose (SRD): Percentage of Subjects With Drug-related Adverse Events. (time frame: From drug administration until 7 days after drug administration, 7 days.). The study lists 3 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 NCT04194645.

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 26 Mar 2024.