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

NCT ID: NCT05865171

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2024-06-12

Brief Summary

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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.

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Detailed Description

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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.).

Conditions

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Renal Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1: Severe Renal Impairment

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

Group Type EXPERIMENTAL

IXP

Intervention Type DRUG

Tablets for oral administration.

Cohort 1: Healthy Participants

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

Group Type EXPERIMENTAL

IXP

Intervention Type DRUG

Tablets for oral administration.

Interventions

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IXP

Tablets for oral administration.

Intervention Type DRUG

Other Intervention Names

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VX-147 Inaxaplin

Eligibility Criteria

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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

Exclusion Criteria

* Uncontrolled hypertension
* Any condition possibly affecting drug absorption
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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GCP Research

Ocala, Florida, United States

Site Status

Genesis Clinical Research

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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VX19-147-007

Identifier Type: -

Identifier Source: org_study_id

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