Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives

Phase 1Not Yet RecruitingNCT07792408

Vertex Pharmaceuticals Incorporated148 enrolled

Overview

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives. 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.).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

VX-407DRUG

Tablets for Oral Administration.

LNG/EEDRUG

Combination Tablets for Oral Administration.

NGM/EEDRUG

Combination Tablets for Oral Administration.

NET/EE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m\^2), inclusive * A total body weight of greater than (\>) 50 kg Key Exclusion Criteria: * History of febrile illness within 5 days before the first dose of study drug * Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug Other protocol defined Inclusion/Exclusion criteria will apply.

Outcomes

Primary Outcomes

Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/EE in the Absence and Presence of VX-407

Time frame: From Day 1 up to Day 7 and Day 21 up to Day 27

Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407

Time frame: From Day 1 up to Day 9 and Day 23 up to Day 31

Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of NET and EE in the Absence and Presence of VX-407

Time frame: From Day 1 up to Day 5 and Day 19 up to Day 23

Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of VX-407

Time frame: From Day 1 up to Day 7 and Day 21 up to Day 27

Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG/EE in the Absence and Presence of VX-407

Time frame: From Day 1 up to Day 7 and Day 21 up to Day 27

Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407

Time frame: From Day 1 up to Day 9 and Day 23 up to Day 31

Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NET and EE in the Absence and Presence of VX-407

Time frame: From Day 1 up to Day 5 and Day 19 up to Day 23

Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of DRSP and EE in the Absence and Presence of VX-407

Central Contacts

Medical Information

CONTACT

617-341-6777 medicalinfo@vrtx.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From Day 1 up to Day 36

Part B (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From Day 1 Up to Day 39

Part C (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From Day 1 up to Day 32

Part D (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From Day 1 up to Day 36

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407

Time frame: Days 9, 15 and 21 up to Day 27

Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

Time frame: Days 11, 17 and 23 up to Day 31

Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

Time frame: Days 7, 13 and 19 up to Day 23

Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

Time frame: Days 9, 15 and 21 up to Day 27

Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

Time frame: Days 9, 15 and 21 up to Day 27

Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

Time frame: Days 11, 17 and 23 up to Day 31

Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

Time frame: Days 7, 13 and 19 up to Day 23

Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

Time frame: Days 9, 15 and 21 up to Day 27