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

Vertex Pharmaceuticals Incorporated74 enrolled

Overview

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.

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

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

VX-407DRUG

Suspension 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

Inclusion Criteria: * Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m\^2) * A total body weight of greater than (\>) 50 kg * Nonsmoker or ex-smoker for at least 12 months before screening * Oral contraceptive naïve or able to comply with 28-day or 5 half-lives (whichever is greater) washout before the start of Period 1 (6-month washout for Depo-Provera) Exclusion Criteria: * History of febrile illness within 5 days before the first dose of study drug * Relative contraindications to hormonal estrogen therapy that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant * Any condition possibly affecting drug absorption, distribution, metabolism, or excretion * Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug * Menopausal, post-menopausal, or documented bilateral oophorectomy and/or hysterectomy * Previously received study drug in this study Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (1)

Altasciences - Kansas City

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Part A: Maximum Observed Plasma Concentration (Cmax) of LNG 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 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 B (Optional): 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 B (Optional): AUC0-inf of NGMN and 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): 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 C (Optional): 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): 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 D (Optional): AUC0-inf 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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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