Status:
COMPLETED
VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.
Lead Sponsor:
Tibotec BVBA
Conditions:
Hepatitis C
Kidney Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 in...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00903773
Start Date
June 1 2009
End Date
February 1 2010
Last Update
December 17 2010
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