Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770 alone and in combination in healthy subjects.

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Detailed Description

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This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-dose study of orally administered VX-809 and VX-770 in healthy subjects. This study will evaluate safety and tolerability of VX-809 and VX-770 alone and in combination.

Subjects will be randomized to receive study drug or placebo during three 14-day treatment periods separated by 14-day washout periods. In Treatment Period 1, subjects randomized to study drug will receive VX-809 every 24 hours. In Treatment Period 2, subjects randomized to study drug will receive VX-770 every 12 hours. In Treatment Period 3, subjects will receive VX-809 every 24 hours and VX-770 every 12 hours. Subjects randomized to placebo will receive placebo during all treatment periods.

Enrollment is planned at 1 clinical site (Lenexa, Kansas). Up to 72 subjects will be enrolled. The study will be separated into 3 dose escalation cohorts. Cohort 1 and Cohort 2 will enroll 24 subjects. Cohort 3 is optional and may be conducted after a review of safety and pharmacokinetic data by Vertex.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Arm

Subjects randomized to study drug will take VX-809 for 14 days followed by a 14 day washout. Next subjects will take VX-770 for 14 days followed by a 14 day washout. Lastly, subjects will take both VX-809 and VX-770 for 14 days.

Group Type EXPERIMENTAL

VX-809

Intervention Type DRUG

capsule, taken once daily

VX-770

Intervention Type DRUG

tablet, taken once every 12 hours

Placebo Arm

Subjects randomized to placebo will take VX-809 placebo for 14 days followed by a 14 day washout. Next subjects will take VX-770 placebo for 14 days followed by a 14 day washout. Lastly, subjects will take both VX-809 and VX-770 placebo for 14 days.

Group Type PLACEBO_COMPARATOR

VX-809 placebo

Intervention Type DRUG

capsule, taken once daily

VX-770 placebo

Intervention Type DRUG

tablet, taken once every 12 hours

Interventions

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VX-809

capsule, taken once daily

Intervention Type DRUG

VX-770

tablet, taken once every 12 hours

Intervention Type DRUG

VX-809 placebo

capsule, taken once daily

Intervention Type DRUG

VX-770 placebo

tablet, taken once every 12 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subject between 18 and 55 years of age, inclusive
* Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive
* Subjects of child bearing potential and who are sexually active must meet the contraception requirements
* Female subject must have a negative serum pregnancy test at screening and Day -1

Exclusion Criteria

* History of any illness that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
* Participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever is longer) before the Screening visit
* Subject who has received VX-770 or VX-809 in a previous clinical study

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes