A VX-121 Study in Healthy Subjects and Subjects With Cystic Fibrosis
Research type
Research Study
Full title
A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis
IRAS ID
250276
Contact name
James Witty
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2018-000126-55
Duration of Study in the UK
0 years, 3 months, 30 days
Research summary
Subjects will participate in Part D of the study.
This study is being done to learn more about the safety and tolerability of the combination of VX-121, Tezacaftor (TEZ) and Ivacaftor (IVA) in patients with Cystic Fibrosis (CF). These drugs are being developed for the treatment of CF.
Study medication will be taken orally (as a tablet) from Day 1 until the morning of Day 29, following a meal containing enough fat to help the drug to be taken up.
Subjects will attend a consent and screening visit and (if eligible), will attend the unit for visits on Day -1, Day 1, Day 8, Day 15 and Day 29 of the treatment period. There will be a safety follow up visit 21-35 days after the last dose of study medication.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0507
Date of REC Opinion
10 Sep 2018
REC opinion
Further Information Favourable Opinion