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

NCT06529796 | Completed Phase 1 FDA Drug

• 1 other identifier: VX20-147-006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Focal Segmental Glomerulosclerosis (FSGS)

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of IXP

  From Day 1 up to Day 10

• 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

Secondary Outcomes (1)

• 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

Study Arms (4)

Cohort 1: Mild Hepatic Impairment

EXPERIMENTAL

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

Drug: IXP

Cohort 2: Matched Healthy Participants

EXPERIMENTAL

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

Drug: IXP

Cohort 3: Moderate Hepatic Impairment

EXPERIMENTAL

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

Drug: IXP

Cohort 4: Matched Healthy Participants

EXPERIMENTAL

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

Drug: IXP

Interventions

IXP DRUG

Tablet for oral administration.

Also known as: VX-147, Inaxaplin

Cohort 1: Mild Hepatic Impairment; Cohort 2: Matched Healthy Participants; Cohort 3: Moderate Hepatic Impairment; Cohort 4: Matched Healthy Participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (3)

Division of Clinical Pharmacology, University of Miami

Miami, Florida, 33136, United States

Location

GCP Research

St. Petersburg, Florida, 33705, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: August 2, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)