CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 65 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
BI-409306 25 milligram (mg) SDfrom 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/NCT01841112
NCT01841112Phase 1Completed
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Safety, Tolerability and Pharmacokinetics of Single Oral Doses of BI 409306 (Tablet) in Healthy Chinese and Japanese Male Volunteers and Multiple Oral Doses of BI 409306 (Tablet) in Healthy Japanese Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Boehringer Ingelheim·interventional·Posted Apr 26, 2013·Updated Jun 25, 2024

In Brief

A Phase 1 clinical trial evaluating Placebo, BI-409306 25 milligram (mg) SD, and 3 other interventions for Healthy. Completed, enrolled 65 participants across 1 site.

Detailed Summary

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 26, 2013
Enrollment StartApr 22, 2013
Primary CompletionJul 18, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.2 years ago

Interventions

Placebodrug

Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment

BI-409306 25 milligram (mg) SDdrug

Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

BI-409306 50 mg SDdrug

Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

BI-409306 100 mg SDdrug

Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

BI-409306 100 mg MDdrug

Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9