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NCT06227832 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Healthy Adults, sponsored by Kaken Pharmaceutical.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT06227832 is a Phase 1 study of Healthy Adults that has completed, run by Kaken Pharmaceutical. The registered enrollment target is 38 participants, below the 85-participant average among 33 other Healthy Adults trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06227832, a Phase 1 study of Healthy Adults, has completed, sponsored by Kaken Pharmaceutical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Midazolam
- DRUG Metformin
- DRUG Clarithromycin
- DRUG KP-001
Study Locations (1)
California
- Parexel Early Phase Clinical Unit - Los Angeles - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-12-15 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06227832
The ClinicalTrials.gov registry entry for NCT06227832 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 85-participant average among 33 other Healthy Adults trials with a reported enrollment target (55% lower). The listed sponsor is Kaken Pharmaceutical, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Adults appearing as the primary indexed condition, and to 4 interventions - of which Midazolam is the first listed.
NCT06227832 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06227832 about?
NCT06227832 is a clinical study titled "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". 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 eva...
What is the current status of trial NCT06227832?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2023-12-15. Estimated completion is 2024-07-31.
What conditions does trial NCT06227832 study?
This clinical trial studies the following conditions: Healthy Adults.
What interventions are being tested in trial NCT06227832?
The interventions under investigation include: Midazolam (DRUG), Metformin (DRUG), Clarithromycin (DRUG), KP-001 (DRUG).
Who is sponsoring clinical trial NCT06227832?
This trial is sponsored by Kaken Pharmaceutical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06227832 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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