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

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Pain

Treatments: Drug: VX-973; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06615570

VX24-973-002

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

Part A: Single Ascending Dose

Experimental group

Description:

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

Treatment:

Drug: VX-973

Part B: Multiple Ascending Dose

Experimental group

Description:

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

Treatment:

Drug: VX-973

Placebo Part A

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Placebo Part B

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo