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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 - Trial NCT06227832

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.

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NCT06227832
Phase 1
Recruitment Completed
drug
Trial Details
ClinicalTrials.gov • NCT06227832
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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

Study Focus

Healthy Adults

KP-001

Interventional

drug

Sponsor & Location

Kaken Pharmaceutical

Glendale, United States of America

Timeline & Enrollment

Phase 1

Dec 15, 2023

Jul 31, 2024

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

Obesity
Healthy person accompanying sick person
Obesity, unspecified
Routine general health check-up of inhabitants of institutions
Lifestyle-related condition

Data Source

ClinicalTrials.gov

NCT06227832

Non-Device Trial