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

NCT04232839 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-09-19

Study results available
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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

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.

Sponsors & Collaborators

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
2020-02-25
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04232839 on ClinicalTrials.gov