Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants
NCT07074327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2026-03-30
Summary
The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE, norethindrone (NET) and EE and drospirenone (DRSP) and EE. Also, to evaluate the safety and tolerability of co-administration of VX-407 with LNG/EE, NGM/EE, NET/EE and DRSP/EE.
Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Interventions
- DRUG
-
VX-407
Suspension for oral administration.
- DRUG
-
LNG/EE
Combination Tablets for Oral Administration.
- DRUG
-
NGM/EE
Combination Tablets for Oral Administration.
- DRUG
-
NET/EE
Combination Tablets for Oral Administration.
- DRUG
-
DRSP/EE
Combination Tablets for Oral Administration.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-11
- Primary Completion
- 2026-02-20
- Completion
- 2026-02-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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