Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Focal Segmental Glomerulosclerosis (FSGS)

Treatments: Drug: IXP

Study type: Interventional

Funder types: Industry

Identifiers

NCT06529796

VX20-147-006

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of Inaxaplin (IXP) in participants with mild or moderate hepatic impairment and in matched 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: 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 Hepatic Impairment

  • Cohort 1 (mild impairment): defined as a Child-Pugh total score of 5 to 6 (Child-Pugh Class A)
  • Cohort 3 (moderate impairment): defined as a Child-Pugh total score of 7 to 9 (Child-Pugh Class B)

• Cohorts 2 and 4: Healthy Participants

  • Participants will be matched during screening to participants with mild (Cohort 1) or moderate (Cohort 3) hepatic impairment according to each of the following parameters: age (± 10 years); sex; and BMI (± 15%)

Key Exclusion Criteria:

• Cohorts 1 and 3: Participants with Hepatic Impairment

  • Acute febrile illness within 14 days and/or acute illness within 5 days before first dose of study drug
  • Participants who smoke

• Cohorts 2 and 4: Healthy Participants

  • Acute febrile illness within 14 days and/or acute illness within 5 days before 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 a single dose of IXP on Day 1.

Treatment:

Drug: IXP

Cohort 2: Matched Healthy Participants

Experimental group

Description:

Healthy participants matched to Cohort 1 will receive a single dose of IXP on Day 1.

Treatment:

Drug: IXP

Cohort 3: Moderate Hepatic Impairment

Experimental group

Description:

Participants will receive a single dose of IXP on Day 1.

Treatment:

Drug: IXP

Cohort 4: Matched Healthy Participants

Experimental group

Description:

Healthy participants matched to Cohort 3 will receive a single dose of IXP on Day 1.

Treatment:

Drug: IXP