A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: APOL1-mediated Kidney Disease

Treatments: Drug: Placebo; Drug: VX-840

Study type: Interventional

Funder types: Industry

Identifiers

NCT05324410

VX21-840-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and PK of single and multiple ascending doses of VX-840 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: 88 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Female participants must be of non-childbearing potential
• Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m^2)
• A total body weight greater than (>) 50 kg

Key Exclusion Criteria:

• History of febrile illness or other acute illness 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: Sequential Assignment

Masking: Quadruple Blind

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88 participants in 4 patient groups, including a placebo group

Part A: VX-840

Experimental group

Description:

Participants will be randomized to receive single dose of one of different dose levels of VX-840.

Treatment:

Drug: VX-840

Part A: Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to VX-840.

Treatment:

Drug: Placebo

Part B: VX-840

Experimental group

Description:

Participants will be randomized to receive multiple doses of one of different dose levels of VX-840. The dose levels will be determined based on the data from Part A.

Treatment:

Drug: VX-840

Part B: Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to VX-840.

Treatment:

Drug: Placebo