At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
BI 201335 +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.
Pharmacokinetics, Safety and Tolerability of BI 201335 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase I Trial
In Brief
A Phase 1 clinical trial evaluating BI 201335 for Hepatitis C. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionJun 2012
TodayJul 2026
First PostedApr 19, 2012
Enrollment StartApr 1, 2012
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.2 years ago
Interventions
BI 201335drug
Relevant treatment dose capsule (A) for oral administration
BI 201335drug
Relevant treatment dose capsule (B) for oral administration