NCT07074327

Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants

Phase 1, Open-label Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Conditions

• Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-11
• Primary completion: 2026-02-20
• Completion: 2026-02-27
• First posted: 2025-07-20
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study