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

NCT ID: NCT05866055

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2024-04-04

Brief Summary

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

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

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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. The dose and frequency will be determined based on Part A. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with study drug on Day 27.

Group Type: EXPERIMENTAL

VX-973

Intervention Type: DRUG

Suspension for oral administration.

Midazolam

Intervention Type: DRUG

Syrup 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. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with placebo matched to VX-973 on Day 27.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Suspension for oral administration.

Midazolam

Intervention Type: DRUG

Syrup for oral administration.

Interventions

VX-973

Suspension for oral administration.

Intervention Type: DRUG

Placebo

Suspension for oral administration.

Intervention Type: DRUG

Midazolam

Syrup for oral administration.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PAREXEL International

Harrow, , United Kingdom

Countries

United Kingdom

Other Identifiers

2022-003301-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VX22-973-001

Identifier Type: -

Identifier Source: org_study_id