NCT03875001

A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1358894 in Healthy Japanese Male Subjects (Double-blind, Randomised, Placebo-controlled Parallel Dose Group Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1358894 in healthy male subjects following oral administration of single rising doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
DRUG	Dose group 1 - 50 mg BI 1358894	2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
DRUG	Dose group 2 - 100 mg BI 1358894	1 film-coated tablet of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
DRUG	Dose group 3 - 200 mg BI 1358894	2 film-coated tablets of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).

Timeline

• Start date: 2019-03-25
• Primary completion: 2019-07-20
• Completion: 2019-07-20
• First posted: 2019-03-14
• Last updated: 2025-02-26
• Results posted: 2025-02-26

Locations

1 site across 1 country: Japan