A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: IXP

• Registration Number: NCT05865171
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of Inaxaplin (IXP) in participants with severe renal impairment and healthy participants with normal renal function.

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: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Study Start: 2023-06-12
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Body mass index (BMI) of 18.5 to 40.0 kilogram per meter square (kg/m^2)
• Stable renal function for at least 1 month prior to enrollment

Key

Exclusion Criteria

• Uncontrolled hypertension
• Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Severe Renal Impairment	IXP	Participants will receive a single dose of IXP on Day 1.
Cohort 1: Healthy Participants	IXP	Participants will receive a single dose of IXP on Day 1.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of IXP	Day 1 up to Day 7
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP	Day 1 up to Day 7

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)	Day 1 through completion of study participation (up to a maximum of 17 days)

Trial Locations

Locations (2)

GCP Research; 🇺🇸 Ocala, Florida, United States

Genesis Clinical Research; 🇺🇸 Tampa, Florida, United States