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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865171
• Other study ID #: VX19-147-007
• Status: Recruiting
• Phase: Phase 1
• Start date: June 12, 2023
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: Medical Information
• Phone: 617-341-6777
• Email: medicalinfo[@]vrtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• IXP
Tablets for oral administration.

Locations

Country	Name	City	State
United States	Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida
United States	Southwest Houston Research, Ltd	Houston	Texas
United States	GCP Research	Ocala	Florida
United States	Genesis Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of IXP		Day 1 up to Day 7
Primary	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	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)