Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: VX-581; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07283770

VX25-581-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581.

Full description

The study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581 in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Note: 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: 128 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
• Male and Female participants of non-childbearing potential

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

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 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-581.

Treatment:

Drug: VX-581

Placebo: Part A

Placebo Comparator group

Description:

Participants will be randomized to receive a single dose of placebo matched to VX-581.

Treatment:

Drug: Placebo

Part B: Multiple Ascending Dose

Experimental group

Description:

Participants will be randomized to receive multiple doses of VX-581.

Treatment:

Drug: VX-581

Placebo: Part B

Placebo Comparator group

Description:

Participants will be randomized to receive multiple doses of placebo matched to VX-581.

Treatment:

Drug: Placebo