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Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function - Trial NCT05711381

Access comprehensive clinical trial information for NCT05711381 through Pure Global AI's free database. This Phase 1 trial is sponsored by Hanmi Pharmaceutical Company Limited and is currently Recruiting. The study focuses on Renal Impairment. Target enrollment is 32 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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NCT05711381
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov • NCT05711381
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Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects With Renal Impairment and Matched Control Subjects With Normal Renal Function

Study Focus

Renal Impairment

HM15912

Interventional

drug

Sponsor & Location

Hanmi Pharmaceutical Company Limited

Tustin,Miami Lakes,Miami,Knoxville, United States of America

Timeline & Enrollment

Phase 1

Dec 02, 2022

Aug 01, 2023

32 participants

Primary Outcome

Maximum serum concentration (Cmax),Area under the concentration-time curve from extrapolated to infinity (AUC 0-infinity)

Summary

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of
 HM15912 in Subjects with Renal Impairment and Matched Control Subjects 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

NCT05711381

Non-Device Trial