CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
BI 730357 +1 moredrug
Likely dose
Not stated in 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/NCT03793621
NCT03793621Phase 1Completed
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Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 730357 in Japanese Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)

Boehringer Ingelheim·interventional·Posted Jan 4, 2019·Updated Jul 12, 2023

In Brief

A Phase 1 clinical trial evaluating BI 730357 and Placebo for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The main objective of this trial is to investigate the safety and tolerability of BI 730357 in Japanese healthy male subjects following oral administration of single rising doses. Secondary objectives are the explorations of the pharmacokinetic(s) (PK), including dose proportionality as well as investigation of linearity of BI 730357 after single dose administration.

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 4, 2019
Enrollment StartJan 21, 2019
Primary CompletionApr 26, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.5 years ago

Interventions

BI 730357drug

single rising oral dose

Placebodrug

single rising oral dose