NCT04232839

A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body

Formulation Selection and Subsequent Optimization of Two Different Oral Formulations of BI 894416 in Healthy Male Subjects (Open-label, Randomised, Single-dose Study in Two Parts; Trial Part 1: Five-period Crossover Design With an Additional Sixth Period in a Fixed Sequence; Trial Part 2: Three-period Crossover Followed by a Two-period Crossover Design)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 principle (tablet vs. capsule) and to optimize the identified extended release formulation of BI 894416, if needed.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 894416 Reference Formulation	R1 - 60 milligram (6 x 10 milligram tablets) BI 894416 Reference Formulation, immediate release (IR) tablets taken orally with 240 mL of water after an overnight fast of at least 10 hours.
DRUG	BI 894416 Formulation A2	T1 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
DRUG	BI 894416 Formulation C2	T2 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation C2, extended release (ER) tablet (slow release rate, SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours. and T5 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation C2, extended release (ER) tablet (slow release rate, SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.
DRUG	BI 894416 Formulation D2	T3 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation D2, extended release (ER) capsule (fast release rate, FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
DRUG	BI 894416 Formulation F2	T4 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation F2, extended release (ER) capsule (slow release rate, SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours. and T6 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation F2, extended release (ER) capsule (slow release rate, SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.

Timeline

• Start date: 2020-02-25
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2020-01-18
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United Kingdom