CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Dose group 1 - 50 mg BI 1358894from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03875001
NCT03875001Phase 1Completed
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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)

Boehringer Ingelheim·interventional·Posted Mar 14, 2019·Updated Feb 26, 2025

In Brief

A Phase 1 clinical trial evaluating Placebo, Dose group 1 - 50 mg BI 1358894, and 2 other interventions for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMar 14, 2019
Enrollment StartMar 25, 2019
Primary CompletionJul 20, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.3 years ago

Interventions

Placebodrug

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).

Dose group 1 - 50 mg BI 1358894drug

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).

Dose group 2 - 100 mg BI 1358894drug

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).

Dose group 3 - 200 mg BI 1358894drug

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).