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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: IXP

Study type: Interventional

Funder types: Industry

Identifiers

NCT05865171

VX19-147-007

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Cohort 1: Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: IXP

Cohort 1: Healthy Participants

Experimental group

Description:

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

Treatment:

Drug: IXP