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NCT06227832

A Study to Determine the Effect of KP-001 on Metformin and Midazolam Pharmacokinetics and the Effect of Clarithromycin on KP-001 Pharmacokinetics in Healthy Adult Participants

An Open-label Study to Determine the Effect of Oral Doses of KP-001 on Metformin and Midazolam Pharmacokinetics After a Single Oral Administration and to Determine the Effect of Clarithromycin on KP-001 Pharmacokinetics After a Single Oral Administration in Healthy Adult Participants
Kaken Pharmaceutical·Phase 1·ClinicalTrials.gov·drugRecruitment Completed
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Adults
Drug/Device/Intervention
KP-001
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Kaken Pharmaceutical
Location
Glendale, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Dec 15, 2023
End date
Jul 31, 2024
Enrollment
38 participants
Primary outcome

Pharmacokinetic (PK) parameters of metformin in plasma: Area under the concentration-time curve from time 0 extrapolated to infinite time (AUCinf),PK parameters of midazolam in plasma: AUCinf,PK parameters of KP-001 in plasma: AUCinf,PK parameters of metformin in plasma: Maximum observed concentration (Cmax),PK parameters of midazolam in plasma: Cmax,PK parameters of KP-001 in plasma: Cmax

Summary

The purpose of this study is to determine the Effects of KP-001 on Metformin (a substrate of
 MATE1) and Midazolam (a substrate of CYP3A4) Pharmacokinetics and the Effect of
 Clarithromycin (potent CYP3A4/P-gp Inhibitor) on KP-001 Pharmacokinetics in Healthy Adult
 Participants. The study will also evaluate the safety and tolerability of KP-001 with and
 without a single dose or multiple doses of an interaction drug. The study comprises 3 parts.
 Participants will stay in the Clinical Unit during the study, depending on which part they
 assigned to. Participants will remain at the clinical site for a 13 day/12 night in-house
 stay (Part 1), a 14 day/13 night in house stay (Part 2), or a 11 day/10 night in-house stay
 (Part 3).

ICD-10 classifications
ObesityHealthy person accompanying sick personObesity, unspecifiedRoutine general health check-up of inhabitants of institutionsLifestyle-related condition
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06227832
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06227832 through Pure Global AI's free database. This Phase 1 trial is sponsored by Kaken Pharmaceutical and is currently Recruitment Completed. The study focuses on Healthy Adults. Target enrollment is 38 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.