NCT05865171

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

Name: Clinical Trial NCT05865171
Creator: Vertex Pharmaceuticals Incorporated
Keywords: Renal Impairment, IXP, Phase 1, drug, clinical trial, United States of America

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

Vertex Pharmaceuticals Incorporated·Phase 1·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Renal Impairment
Drug/Device/Intervention: IXP
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Vertex Pharmaceuticals Incorporated
Location: Edgewater,Ocala, United States of America

Timeline & enrollment

Phase: Phase 1
Start date: Jun 12, 2023
End date: Dec 01, 2023
Enrollment: 16 participants

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of IXP,Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP

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.

ICD-10 classifications

Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05865171
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05865171 through Pure Global AI's free database. This Phase 1 trial is sponsored by Vertex Pharmaceuticals Incorporated and is currently Recruiting. The study focuses on Renal Impairment. Target enrollment is 16 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.