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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Ivacaftor; VX-659

Criteria

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.