Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT06227832
Brief 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).
Study:
NCT06227832
Study Brief:
Protocol Section:
NCT06227832