VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00903773
Study type	Interventional
Source	Tibotec BVBA
Contact
Status	Completed
Phase	Phase 1
Start date	June 2009
Completion date	February 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03686722` - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin	Phase 1
Recruiting	`NCT04510246` - Link Hepatitis C Notifications to Treatment in Tasmania	N/A
Completed	`NCT03413696` - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed	`NCT03118674` - Harvoni Treatment Porphyria Cutanea Tarda	Phase 2
Completed	`NCT03109457` - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
Completed	`NCT01458054` - Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults	Phase 1
Completed	`NCT03740230` - An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Completed	`NCT03426787` - Helping Empower Liver and Kidney Patients	N/A
Completed	`NCT03627299` - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors	Phase 4
Completed	`NCT00006301` - Immune Response to Hepatitis C Virus
Active, not recruiting	`NCT03949764` - The Kentucky Viral Hepatitis Treatment Study	Phase 4
Completed	`NCT03365635` - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C	Phase 4
Recruiting	`NCT04405024` - Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients	N/A
Completed	`NCT04525690` - Improving Inpatient Screening for Hepatitis C	N/A
Completed	`NCT04033887` - Evaluation Study of RDTs Detecting Antibodies Against HCV
Withdrawn	`NCT04546802` - HepATocellular Cancer Hcv Therapy Study	Phase 3
Active, not recruiting	`NCT02961426` - Strategic Transformation of the Market of HCV Treatments	Phase 2/Phase 3
Completed	`NCT02992184` - PoC-HCV Genedrive Viral Detection Assay Validation Study	N/A
Completed	`NCT02869776` - Integrating HCV and HIV Screening During the Era of HIV Antigen Testing	N/A
Completed	`NCT02683005` - Study of Hepatitis C Treatment During Pregnancy	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms