CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
BI 1467335drug
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/NCT03302091
NCT03302091Phase 1Completed
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Pharmacokinetics, Safety and Tolerability After Multiple Dose Administration of BI 1467335 in Subjects With Moderate Renal Impairment and Subjects With Normal Renal Function (a Mono-centric, Open-label Study in Matched-group Design)

Boehringer Ingelheim·interventional·Posted Oct 4, 2017·Updated Jun 4, 2021

In Brief

A Phase 1 clinical trial evaluating BI 1467335 for Renal Insufficiency and Healthy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The primary objective of the current study is to investigate the influence of moderate renal impairment on the pharmacokinetics of multiple doses in comparison to a matched control group with normal renal function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency, Healthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 4, 2017
Enrollment StartOct 17, 2017
Primary CompletionAug 16, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.7 years ago

Interventions

BI 1467335drug

28 day treatment period