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

Phase 1

Completed

• Conditions: Focal Segmental Glomerulosclerosis (FSGS)
• Interventions: Drug: IXP

• Registration Number: NCT06529796
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.).

Study Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Study First Posted: 2024-07-31
• Study Start: 2024-08-02
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Mild Hepatic Impairment	IXP	Participants will receive a single dose of IXP on Day 1.
Cohort 2: Matched Healthy Participants	IXP	Healthy participants matched to Cohort 1 will receive a single dose of IXP on Day 1.
Cohort 4: Matched Healthy Participants	IXP	Healthy participants matched to Cohort 3 will receive a single dose of IXP on Day 1.
Cohort 3: Moderate Hepatic Impairment	IXP	Participants will receive a single dose of IXP on Day 1.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP	From Day 1 up to Day 10
Maximum Observed Plasma Concentration (Cmax) of IXP	From Day 1 up to Day 10

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to Day 20

Trial Locations

Locations (3)

Division of Clinical Pharmacology, University of Miami; 🇺🇸 Miami, Florida, United States

GCP Research; 🇺🇸 Saint Petersburg, Florida, United States

Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States