CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 83 enrolled
Drug / intervention
BI 730357 +2 moredrug
Likely dose
Midazolam 200 mgfrom 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/NCT03279978
NCT03279978Phase 1Completed
CompareCT.gov

Phase Ib Evaluation of the Safety and Tolerability and Effect on Midazolam Metabolism of the Administration of Multiple Rising Doses of BI 730357 to Healthy Volunteers

Boehringer Ingelheim·interventional·Posted Sep 12, 2017·Updated Dec 19, 2024

In Brief

A Phase 1 clinical trial evaluating BI 730357, Placebo, and 1 other intervention for Healthy and Psoriasis. Completed, enrolled 83 participants across 1 site.

Detailed Summary

Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy volunteers for up to 28 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Psoriasis
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedSep 12, 2017
Enrollment StartJan 9, 2018
Primary CompletionAug 24, 2018
Study CompletionAug 30, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.8 years ago

Interventions

BI 730357drug

BI 730357 film-coated tablet

Placebodrug

Placebo

Midazolamdrug

Once per day (QD) on Days -1, 3, and 14. Dose groups BI 730357 200 mg fed and BI 730357 400 mg fed