Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: VX-548

Study type: Interventional

Funder types: Industry

Identifiers

NCT05560464

VX21-548-007

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.

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: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment

  • Participants will satisfy the criteria for mild (Cohort 1) and moderate hepatic impairment (Cohort 3) defined as a Child-Pugh total score of 5 to 6 and 7 to 9 points, respectively at the screening visit
  • Participants will have chronic (greater than or equal to (≥) 6 months) documented liver disease

• Cohorts 2 and 4: Matched Healthy Participants

  • Participants will be matched (cohort 2 matched to cohort 1; and cohort 4 matched to cohort 3) during screening to participants with hepatic impairment for age, sex, and weight

Key Exclusion Criteria:

• Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment

  • History of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug
  • Severe portal hypertension
  • History or presence of severe hepatic encephalopathy (Grade >2)
  • Any condition possibly affecting drug absorption
  • Significant renal dysfunction (creatinine clearance <60 milliliter per minute [mL/min] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1
  • History of solid organ or bone marrow transplantation

• Cohorts 2 and 4: Matched Healthy Participants

  • History of febrile illness or other acute illness that has not fully resolved by 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: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Cohort 1: Mild Hepatic Impairment

Experimental group

Description:

Participants will receive multiple doses of VX-548 every 12 hours (q12h) from Day 1 through Day 14.

Treatment:

Drug: VX-548

Cohort 2: Matched Healthy Participants

Experimental group

Description:

Healthy participants matched to cohort 1 will receive multiple doses of VX-548 q12h from Day 1 through Day 14.

Treatment:

Drug: VX-548

Cohort 3: Moderate Hepatic Impairment

Experimental group

Description:

Participants will receive multiple doses of VX-548 q12h from Day 1 through Day 14.

Treatment:

Drug: VX-548

Cohort 4: Matched Healthy Participants

Experimental group

Description:

Healthy participants matched to cohort 3 will receive multiple doses of VX-548 q12h from Day 1 through Day 14.

Treatment:

Drug: VX-548