Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: VX-548

Study type: Interventional

Funder types: Industry

Identifiers

NCT05704556

VX22-548-014

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe or moderate renal impairment and 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: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment

  • Body mass index (BMI) of greater than or equal to (>=)18.0 to less than (<) 40.0 kilogram per square meter (kg/m^2)
  • Stable renal function as pre-defined in the protocol

• Cohorts 2 and 4: Matched Healthy Participants

  • Healthy participants will be matched to Cohorts 1 and 3 participants according to each of the following parameters: sex, age (±10 years), and BMI (±15%)

Key Exclusion Criteria:

• Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment

  • Hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screening

• Cohorts 2 and 4: Matched Healthy Participants

  • Prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis

• All Cohorts:

  • History of febrile or acute illness that has not fully resolved by 14 days before study drug dosing.
  • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 4 patient groups

Cohort 1: Severe Renal Impairment

Experimental group

Description:

Participants will receive a single dose of VX-548 in a fasted state.

Treatment:

Drug: VX-548

Cohort 2: Matched Healthy Participants

Experimental group

Description:

Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state.

Treatment:

Drug: VX-548

Cohort 3: Moderate Renal Impairment

Experimental group

Description:

Participants will receive a single dose of VX-548 in a fasted state.

Treatment:

Drug: VX-548

Cohort 4: Matched Healthy Participants

Experimental group

Description:

Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state.

Treatment:

Drug: VX-548