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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Kaken Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	KP-001	KP-001
DRUG	Metformin	oral dose of 850 mg Metformin
DRUG	Midazolam	oral dose of 2 mg Midazolam
DRUG	Clarithromycin	oral doses of 1000 mg Clarithromycin

Timeline

• Start date: 2023-12-15
• Primary completion: 2024-03-15
• Completion: 2024-07-31
• First posted: 2024-01-29
• Last updated: 2025-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study