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

A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Safety of a Single Dose of Inaxaplin in Subjects With Severe Renal Impairment and Healthy Subjects With Normal Renal Function

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05865171

Enrollment

Registered

2023-05-18

Start date

2023-06-12

Completion date

2024-06-12

Last updated

2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

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.).

Interventions

DRUGIXP

Tablets for oral administration.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Key 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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026