A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis

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

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-08-31

Brief Summary

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Evaluate the safety and tolerability of VX-659 in healthy subjects

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Detailed Description

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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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Part A: VX-659 or Matching Placebo

Part A includes single-dose escalation.

Group Type EXPERIMENTAL

VX-659

Intervention Type DRUG

VX-659 Matching Placebo

Intervention Type DRUG

Part B: VX-659 or Matching Placebo

Part B includes multiple-dose escalation.

Group Type EXPERIMENTAL

VX-659

Intervention Type DRUG

VX-659 Matching Placebo

Intervention Type DRUG

Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo

Part C includes multiple dose escalation of VX-659 administered in Triple Combination (TC).

Group Type EXPERIMENTAL

VX-659

Intervention Type DRUG

Tezacaftor

Intervention Type DRUG

Ivacaftor

Intervention Type DRUG

Triple Combination (TC) Matching Placebos

Intervention Type DRUG

Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo

Part D includes subjects with CF. Participants will receive TC or matching placebos.

Group Type EXPERIMENTAL

VX-659

Intervention Type DRUG

Tezacaftor

Intervention Type DRUG

Ivacaftor

Intervention Type DRUG

Triple Combination (TC) Matching Placebos

Intervention Type DRUG

Interventions

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VX-659

Intervention Type DRUG

Tezacaftor

Intervention Type DRUG

Ivacaftor

Intervention Type DRUG

VX-659 Matching Placebo

Intervention Type DRUG

Triple Combination (TC) Matching Placebos

Intervention Type DRUG

Other Intervention Names

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VX-661 TEZ VX-770 IVA

Eligibility Criteria

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Inclusion Criteria

Healthy Volunteers: PARTS A, B, and C

* Males and Females of non-childbearing potential.
* Between the ages of 18 and 60 years inclusive
* Healthy, as defined per protocol.
* Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive
* Body weight \>50 kg

CF Patients: PART D

* Body weight ≥35 kg.
* Males and Females of non-childbearing potential.
* Sweat chloride value ≥ 60 mmol/L at screening.
* Heterozygous for F508del and a minimal function CFTR mutation
* Forced expiratory volume in 1 second (FEV1) ≥40% and ≤90% of predicted at screening

Exclusion Criteria

Healthy Volunteers: PARTS A, B, and C

* History of any illness or any clinical condition that in the opinion of the investigator might confound the results of the study or pose additional risk to the subject.
* Any condition possibly affecting drug absorption.
* History of febrile illness within 14 days before the first study drug dose.
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening.

CF Patients: PART D

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject.
* History of cirrhosis with portal hypertension.
* Risk factors for Torsade de Pointes.
* G6PD deficiency assessed at Screening.
* Abnormal Laboratory Values.
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* History of solid organ or hematological transplantation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes