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

Vertex Pharmaceuticals Incorporated48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

VX-809DRUG

capsule, taken once daily

VX-770DRUG

tablet, taken once every 12 hours

VX-809 placeboDRUG

capsule, taken once daily

VX-770 placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PRA

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

PK parameters (including concentration, exposure and half-life) of VX-809 and its metabolite in plasma in the presence and absence of VX 770

Blood samples drawn during the study will be analyzed to measure the PK parameters, such as concentration, exposure and half-life of VX-809 and its metabolite.

Time frame: 70 days

PK parameters (including concentration, exposure and half-life) of VX-770 and its metabolites in plasma in the presence and absence of VX 809

Blood samples drawn during the study will be analyzed to measure the PK parameters, such as concentration, exposure and half-life of VX-770 and its metabolites.

Time frame: 70 days

Secondary Outcomes

Safety and tolerability as measured by adverse events (AEs) and clinically significant changes in laboratory values (clinical chemistry, hematology, coagulation, and urinalysis), electrocardiograms, and vital signs

Time frame: 70 days

Data from ClinicalTrials.gov

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