Effects of VX-659 triple combination on Oral contraceptives in Females
Research type
Research Study
Full title
A Phase 1, Open-label, 2-Part, 2-Period, 1-Way Crossover Study to Evaluate the Effect of VX-659 Triple Combination Therapy on the Pharmacokinetics of Oral Contraceptives in Healthy Adult Female Subjects.
IRAS ID
240187
Contact name
Jennifer Dittman
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2017-002740-33
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
The study drug called VX-659 is a potential new medication that is being developed for the treatment of Cystic Fibrosis (CF). CF is a chronic is a genetic disease that results in damage to the lungs and other organs, by causing the body to produce unusually thick mucus. At present, there is no cure for this disease. \n\nThe purpose of the study is to look at the effects of VX-659, in combination with two other CF medications called ‘Ivacaftor’ and ‘Tezacaftor’, and an oral contraceptive called ‘levonorgestrel and ethinylestradiol’ or an oral contraceptive called ‘norethisterone’. Previous data shows that it is possible that these study medications may affect the effectiveness of the oral contraceptive pills, therefore the purpose of this study is to further investigate this.\n\nThis study is split into two parts: \n\n- Part A will look VX-659, Ivacaftor and Tezacaftor when taken at the same time as hormonal oral contraceptive containing levonorgestrel and ethinylestradiol. Subjects will have two treatment periods. Treatment period one will last 14 days and will require subjects to take a hormonal oral contraceptive containing levonorgestrel and ethinylestradiol. Treatment period two will last for 10 days and will require subjects to take a hormonal oral contraceptive containing levonorgestrel and ethinylestradiol in addition to VX-659, in combination with Ivacaftor and Tezacaftor.\n\n- Part B will look VX-659, Ivacaftor and Tezacaftor when taken at the same time as hormonal oral contraceptive containing norethisterone. Subjects will have two treatment periods. Treatment period one will last 3 days and will require subjects to take a hormonal oral contraceptive containing norethisterone. Treatment period two will last for 10 days and will require subjects to take a hormonal oral contraceptive containing norethisterone in addition to VX-659, in combination with Ivacaftor and Tezacaftor.\n\nSubjects will participate in ONE Part only.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0010
Date of REC Opinion
5 Feb 2018
REC opinion
Further Information Favourable Opinion