Back to resultsVX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.
Primary Purpose
Hepatitis C, Kidney Diseases
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
telaprevir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring VX-950-TiDP24-C132, VX-950-C132, VX-950, HCV
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The effect of severe renal impairment on total and unbound plasma concentrations of the sum of TVR and VRT-127394 will be investigated.
Safety and tolerability of a single dose of telaprevir will be determined.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00903773
Brief Title
VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.
Official Title
A Phase I Open-label Trial to Investigate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Telaprevir.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tibotec BVBA
4. Oversight
5. Study Description
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.
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/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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Kidney Diseases
Keywords
VX-950-TiDP24-C132, VX-950-C132, VX-950, HCV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
telaprevir
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
Safety and tolerability of a single dose of telaprevir will be determined.
Time Frame
This will be determined throughout the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibotec-Virco Virology BVBA Clinical Trial
Organizational Affiliation
Tibotec BVBA
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.
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