Clinical trial NCT06529796: Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Focal Segmental Glomerulosclerosis (FSGS)
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-07-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.).

Eligibility 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of IXP
timeFrame: From Day 1 up to Day 10
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP
timeFrame: From Day 1 up to Day 10
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 20
Other outcomes:
Locations:
city: Miami
country: United States
facility: Division of Clinical Pharmacology, University of Miami
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research
state: Florida
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
Study officials:
References: