A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2024-07-02

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics (PK), drug-drug interaction, and safety and tolerability of VX-993 in healthy participants.

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Detailed Description

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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

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Midazolam

Participants will receive a single dose of Midazolam in absence and presence of VX-993.

Group Type EXPERIMENTAL

VX-993

Intervention Type DRUG

Suspension for Oral Administration.

Midazolam

Intervention Type DRUG

Solution for Oral Administration.

Part B: Itraconazole

Participants will receive a single dose of VX-993 on Day 1 and Itraconazole once daily (qd) on Days 7 through Day 15. On Day 10 participants will receive Itraconazole followed by VX-993.

Group Type EXPERIMENTAL

VX-993

Intervention Type DRUG

Suspension for Oral Administration.

Itraconazole

Intervention Type DRUG

Capsules for Oral Administration.

Part C: Gemfibrozil

Participants will receive a single dose of VX-993 on Day 1 and Gemfibrozil every 12 hours (q12d) on Days 7 through Day 15. On Day 10 participants will receive Gemfibrozil followed by VX-993.

Group Type EXPERIMENTAL

VX-993

Intervention Type DRUG

Suspension for Oral Administration.

Gemfibrozil

Intervention Type DRUG

Tablets for Oral Administration.

Interventions

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VX-993

Suspension for Oral Administration.

Intervention Type DRUG

Gemfibrozil

Tablets for Oral Administration.

Intervention Type DRUG

Itraconazole

Capsules for Oral Administration.

Intervention Type DRUG

Midazolam

Solution for Oral Administration.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Nonsmoker or ex-smoker for at least 3 months before the first study drug dose

Exclusion Criteria

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug.
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes