TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.
|ClinicalTrials.gov Identifier: NCT00736905|
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : April 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV AIDS Hepatic Impairment||Drug: TMC278||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||November 2009|
- The primary objective of this study is to assess the single-dose and steady-state pharmacokinetics of TMC278 in subjects with mild or moderate hepatic impairment compared to matched healthy control subjects.
- The secondary objective of this study is to assess the short-term safety and tolerability of TMC278 in subjects with mild or moderate hepatic impairment compared to matched healthy control subjects.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736905
|Study Director:||Tibotec Pharmaceuticals Clinical Trial||Tibotec Pharmaceutical Limited|