CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
BI 1015550 +1 moredrug
Likely dose
BI 1015550 6 milligramfrom 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/NCT03422068
NCT03422068Phase 1Completed
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Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy.

Boehringer Ingelheim·interventional·Posted Feb 5, 2018·Updated Nov 28, 2025

In Brief

A Phase 1 clinical trial evaluating BI 1015550 and Placebo for Idiopathic Pulmonary Fibrosis. Completed, enrolled 15 participants across 11 sites in 7 countries.

Detailed Summary

The primary objective is to investigate safety and tolerability of BI 1015550 in patients with IPF. The secondary objectives are to evaluate the pharmacokinetics (PK) of BI 1015550 in patients with IPF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesDenmark, Finland, Germany, Italy, Netherlands, Spain, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedFeb 5, 2018
Enrollment StartMar 16, 2018
Primary CompletionJul 1, 2019
Study CompletionJul 10, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.4 years ago

Interventions

BI 1015550drug

3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid).

Placebodrug

3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily.