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A Phase 1 Dose Escalation Study of VX-973 in Healthy Participants

NCT ID: NCT06615570

Last Updated: 2025-08-26

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-07-21

Brief Summary

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The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 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

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Single Ascending Dose

Participants will be randomized to receive a single dose of VX-973 under fasted conditions.

Group Type EXPERIMENTAL

VX-973

Intervention Type DRUG

Suspension for oral administration.

Part B: Multiple Ascending Dose

Participants will be randomized to receive multiple doses of VX-973 under fasted conditions.

Group Type EXPERIMENTAL

VX-973

Intervention Type DRUG

Suspension for oral administration.

Placebo Part A

Participants will be randomized to receive placebo matched to VX-973.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Suspension for oral administration.

Placebo Part B

Participants will be randomized to receive placebo matched to VX-973.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Suspension for oral administration.

Interventions

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VX-973

Suspension for oral administration.

Intervention Type DRUG

Placebo

Suspension 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
* Participants of non-childbearing potential
* Nonsmoker or ex-smoker for at least 3 months before screening

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

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ICON Salt Lake City

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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VX24-973-002

Identifier Type: -

Identifier Source: org_study_id

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