A Study in Healthy Men to Find Out How Different Doses of BI 3009947 Are Tolerated and How Different Formulations or Food Influence How BI 3009947 is Taken up Into the Blood
NCT07250048 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-04-01
Summary
Single-rising dose (SRD) part:
The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following oral administration of single rising doses.
Bioavailability (BA) part:
The main objective of the BA part is to investigate the relative bioavailability of two different BI 3009947 formulations (Formulation A and B) and to assess the influence of food on the relative bioavailability of Formulation A or B.
Conditions
- Healthy
Interventions
- DRUG
-
BI 3009947 (Formulation A)
BI 3009947 (Formulation A)
- DRUG
-
BI 3009947 (Formulation B)
BI 3009947 (Formulation B)
- DRUG
-
Placebo matching BI 3009947 (Formulation A)
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-21
- Primary Completion
- 2026-03-02
- Completion
- 2026-03-02
Countries
- Germany
Study Locations
More Related Trials
-
A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food
NCT05337592 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321
NCT03971695 ·Status: COMPLETED ·Phase: PHASE1
-
To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers
NCT03004404 ·Status: COMPLETED ·Phase: PHASE1
-
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood
NCT03100916 ·Status: COMPLETED ·Phase: PHASE1
-
This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body
NCT03230487 ·Status: COMPLETED ·Phase: PHASE1
-
This Study in Healthy Men Tests How Different Doses of BI 894416 Are Taken up in the Body and How Well BI 894416 is Tolerated
NCT03315936 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers
NCT01541488 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
NCT04065295 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469
NCT01971502 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
NCT03123185 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
NCT04445090 ·Status: TERMINATED ·Phase: PHASE1
-
A Study in Healthy Men Tests How Different Doses of BI 764198 Are Taken up in the Body and How Well They Are Tolerated.
NCT03854552 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667
NCT02133482 ·Status: WITHDRAWN ·Phase: PHASE1
-
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.
NCT04194645 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How Well Different Doses of BI 3810477 Are Tolerated by Healthy Men
NCT06631430 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood
NCT03892616 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood
NCT03794323 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men and Women to Test How BI 3000202 is Taken up and Processed by the Body
NCT07273474 ·Status: COMPLETED ·Phase: PHASE1
-
This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood.
NCT03483077 ·Status: TERMINATED ·Phase: PHASE1
-
This Study Tests How Different Doses of BI 1291583 Are Taken up in the Body and How Well They Are Tolerated
NCT03414008 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men
NCT03837964 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How Well Different Doses of BI 1815368 Are Tolerated by Healthy Men
NCT05857878 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions
NCT01897597 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men
NCT03802331 ·Status: COMPLETED ·Phase: PHASE1