NCT04926246

A Study in Healthy Men to Find the Best Formulation of BI 685509 and to Test How it is Taken up in the Body

Formulation Selection and Subsequent Optimization of Oral Formulations of BI 685509 in Healthy Male Subjects (Open-label, Randomized, Single-dose Design Study in up to Three Parts; Trial Part 1: Five-period Crossover; Optional Trial Parts 2 & 3: Fourperiod Crossover)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-02-07
• Completion: 2022-02-07
• First posted: 2021-06-15
• Last updated: 2022-12-09

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study