Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

• Status: Completed
• Trial end date: 2019-05-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis (CF).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Ivacaftor

Criteria

Key Inclusion Criteria:

• Part A, B, and C: Healthy Volunteers

• Female subjects must be of non-childbearing potential

• Between the ages of 18 and 55 years, inclusive

• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

• Part D: Subjects with CF

• Heterozygous for F508del and an MF mutation (F/MF)

• FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height

• Body weight ≥35 kg

Key Exclusion Criteria:

• Part A, B and C: Healthy Volunteers

• Any condition possibly affecting drug absorption

• History of febrile illness or other acute illness within 5 days before the first study drug dose

• Part D: Subjects with CF

• History of clinically significant cirrhosis with or without portal hypertension

• History of solid organ or hematological transplantation

• Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria may apply