- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00903773
VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.
December 16, 2010 updated by: Tibotec BVBA
A Phase I Open-label Trial to Investigate the Effect of Severe Renal Impairment on the Single-dose 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 Overview
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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 Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
Time Frame: This will be determined throughout the study.
|
This will be determined throughout the study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
May 14, 2009
First Submitted That Met QC Criteria
May 14, 2009
First Posted (Estimate)
May 18, 2009
Study Record Updates
Last Update Posted (Estimate)
December 17, 2010
Last Update Submitted That Met QC Criteria
December 16, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR016123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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