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A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment - Trial NCT05865171

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.

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NCT05865171
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05865171
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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

Study Focus

Renal Impairment

IXP

Interventional

drug

Sponsor & Location

Vertex Pharmaceuticals Incorporated

Edgewater,Ocala, United States of America

Timeline & Enrollment

Phase 1

Jun 12, 2023

Dec 01, 2023

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 failure
Disorders resulting from impaired renal tubular function
Disorder resulting from impaired renal tubular function, unspecified
Other disorders resulting from impaired renal tubular function
Acute renal failure

Data Source

ClinicalTrials.gov

NCT05865171

Non-Device Trial