A Study in Healthy Men to Find the Best Formulation of BI 685509 and to Test How it is Taken up in the Body
NCT04926246 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2022-12-09
Summary
The main objective of this trial is to select a formulation and to optimize the identified formulation of BI 685509, if needed.
Conditions
- Healthy
Interventions
- DRUG
-
R1: Reference Product X
under fasted conditions
- DRUG
-
T1: Test Product M
under fasted conditions
- DRUG
-
T2: Test Product N
under fasted conditions
- DRUG
-
T3: Test Product O
under fasted conditions
- DRUG
-
T4: Test Product O
under fed conditions
- DRUG
-
R2: Reference Product Y
under fasted conditions
- DRUG
-
T5: Test Product P
under fasted conditions
- DRUG
-
T6: Test Product P
under fed conditions
- DRUG
-
T7: Test Product Q
under fasted conditions
- DRUG
-
R3: Reference Product Z
under fasted conditions
- DRUG
-
T8: Test Product S
under fasted conditions
- DRUG
-
T9: Test Product S
under fed conditions
- DRUG
-
T10: Test Product U
under fasted conditions
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-01
- Primary Completion
- 2022-02-07
- Completion
- 2022-02-07
- FDA Drug
- Yes
Countries
- United Kingdom
Study Locations
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