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

NCT00903773 | Completed Phase 1

• 1 other identifier: CR016123
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis C; Kidney Diseases

Keywords

VX-950-TiDP24-C132; VX-950-C132; VX-950; HCV

Outcome Measures

Primary Outcomes (1)

• 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.

  Pharmacokinetic profiles of total TVR up to 24 hours postdose will be determined. Twenty-four hour urine will be collected for estimation of CrCl.

Secondary Outcomes (2)

• The effect of severe renal impairment on total and unbound plasma concentrations of the sum of TVR and VRT-127394 will be investigated.

  Blood samples will be taken at specific timepoints within the 24-hour postdose period.

• Safety and tolerability of a single dose of telaprevir will be determined.

  This will be determined throughout the study.

Interventions

telaprevir DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males are allowed and females of childbearing potential if adequate contraception is used. Females of non-childbearing potential should be amenorrheal for at least 2 years, or have undergone tubal ligation (or other permanent birth control methods), or hysterectomy (total), or oophorectomy (bilateral)
• For participants with severe renal impairment: consistent with the disease process of chronic renal failure and associated symptoms, otherwise judged to be in good health in the opinion of the investigator on the basis of a medical evaluation (including a physical examination, medical history, electrocardiogram (ECG), vital signs, and screening laboratory tests), with any concomitant medical conditions under stable medical control
• For participants with severe renal impairment: creatinine clearance \< 30 mL/min (Cockcroft-Gault)
• For healthy controls: healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, ECG, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening

You may not qualify if:

• A history of any illness (unrelated to renal impairment, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study medication to the participant. This may include but is not limited to: diabetes mellitus, history of relevant drug or food allergies
• history of cardiovascular or central nervous system disease
• history or presence of clinically significant pathology, chronic skin disease, or history of mental disease
• For subjects with severe renal impairment: history of renal transplant or renal carcinoma. Participants with a history of renal carcinoma who have been cancer free for at least 5 years may be included
• For participants with severe renal impairment: participants with End Stage Renal Disease (ESRD) requiring dialysis
• For healthy controls: current use of prescription medication and regular treatment with over-the-counter medications

Sponsors & Collaborators

• Tibotec BVBA: lead

MeSH Terms

Conditions

Hepatitis C; Kidney Diseases

Interventions

telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 18, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 17, 2010

Record last verified: 2010-12