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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 25, 2020

Primary Completion Date

November 30, 2020

Study Completion Date

November 30, 2020

Conditions

Healthy

Interventions

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."

Trial Locations (1)

NG11 6JS

Quotient Sciences, Nottingham