Clinical trial NCT01511432: A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
Official title: A Two-Part, Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of 3 Novel Oral Formulations of Telaprevir Relative to Incivek 375-mg Tablets When Administered as a Single 1125-mg Dose to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Relative bioavailability
telaprevir formulations
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years
* Non-childbearing potential female subjects
* Male subjects and female partners must agree to use at least 2 methods of contraception
* Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh \>50 kg at the Screening Visit.

Exclusion Criteria:

* Subjects with a positive test result for hepatitis B, hepatitis C, or HIV
* Subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption
* Subjects with a positive urine screen for drugs of abuse
* Subjects with a history of regular alcohol consumption
* Subjects treated with an investigational drug within 30 days
* For Part A only: Subjects with 12-lead ECG QTcF \>450 msec (males) or QTcF \>470 msec (females) at the Screening Visit
* Subjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements
* Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug
* Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
* Subjects on hormone replacement therapy (HRT) must discontinue such therapy 28 days prior to the first dose of study drug
* Subjects who have a habit of using tobacco or nicotine containing products within 6 months before the Screening Visit

Primary outcomes:
measure: PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)
timeFrame: Up to 57 days
measure: • PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast)
timeFrame: Up to 57 Days
Secondary outcomes:
measure: The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms
timeFrame: Up to 57days
measure: Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir
timeFrame: Up to 57 Days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas
state: Texas
city: Madison
country: United States
facility: Wisconsin
state: Wisconsin
Study officials:
References: