VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.
The purpose of this study is to investigate the effect of severe renal impairment or failure on the single-dose pharmacokinetics of telaprevir (TVR). Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. In addition, the effect of severe renal impairment on the total and unbound plasma concentrations of the sum of TVR and its R-diastereomer VRT-127394 will be assessed. (Diastereomers are substances whose chemical structures are mirror images of each other). Finally, the short-term safety and tolerability of TVR in participants with severe kidney disease will be determined. The results of this study will guide dose recommendations for TVR in subjects with kidney disease.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Open-label Trial to Investigate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Telaprevir.|
- The primary objective of this study is to investigate the effect of severe renal impairment on the single-dose pharmacokinetics of total telaprevir. Total telaprevir is the sum of telaprevir bound to plasma proteins and unbound (free) telaprevir. [ Time Frame: Pharmacokinetic profiles of total TVR up to 24 hours postdose will be determined. Twenty-four hour urine will be collected for estimation of CrCl. ] [ Designated as safety issue: No ]
- The effect of severe renal impairment on total and unbound plasma concentrations of the sum of TVR and VRT-127394 will be investigated. [ Time Frame: Blood samples will be taken at specific timepoints within the 24-hour postdose period. ] [ Designated as safety issue: No ]
- Safety and tolerability of a single dose of telaprevir will be determined. [ Time Frame: This will be determined throughout the study. ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
This is a Phase I, open-label trial to investigate the single-dose pharmacokinetics of telaprevir (TVR) in 12 participants with severe renal impairment (defined as creatinine clearance (CrCl) < 30 mL/min) as compared to 12 participants with normal renal function, matched for sex, race, age (± 10 years) and BMI (± 20%). Open-label means that the study doctor and the participants know what treatment will be assigned to them. All participants will receive a single 750-mg dose of TVR. Pharmacokinetic profiles of total TVR up to 24 hours postdose will be determined. A 24 hour urine collection test will be performed to estimate the CrCl. In addition, the effect of severe renal impairment on the total and unbound plasma concentrations of the sum of TVR and VRT-127394 will be assessed. Tolerability and safety of TVR will be assessed throughout the trial period. Illnesses and side effects will be checked at every visit. Blood and urine samples will be taken at screening, on Day 1, 2 and at the 2 follow-up visits. ECG and vital signs will be taken at screening, twice on day 1, on day 2 and at the first follow-up visit. At the second follow-up visit vital signs alone will be determined. A physical examination will be done at screening, on the day before TVR intake, on day 2 and at both follow-up visits. All participants will receive a single 750-mg dose of telaprevir (TVR) given by mouth as 2 tablets of 375 mg.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903773
|Study Director:||Tibotec-Virco Virology BVBA Clinical Trial||Tibotec BVBA|