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

A Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of a Single Dose of Inaxaplin in Subjects With Mild or Moderate Hepatic Impairment and in Matched Healthy Subjects

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.

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.).

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