At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
BI 10773drug
Likely dose
BI 10773 25 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.
Pharmacokinetics, Safety and Tolerability of BI 10773 50 mg Single Dose in Male and Female Subjects With Different Degrees of Liver Impairment (Child-Pugh Classification A, B and C) as Compared to Male and Female Healthy Subjects (a Non-blinded, Parallel Group Study of Phase I)
In Brief
A Phase 1 clinical trial evaluating BI 10773 for Hepatic Insufficiency and Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Insufficiency, Healthy
CountriesRomania
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartJul 2010
Primary CompletionNov 2010
TodayJul 2026
First PostedApr 27, 2010
Enrollment StartJul 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.2 years ago
Interventions
BI 10773drug
2 tablets BI 10773 25 mg single dose