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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

Healthy Adults Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06227832
Study type Interventional
Source Kaken Pharmaceutical
Contact
Status Active, not recruiting
Phase Phase 1
Start date December 15, 2023
Completion date July 31, 2024
View Details
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