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NCT06821698 · ClinicalTrials.gov registry record · Phase 1
To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers
A Phase 1 study, sponsored by Kaken Pharmaceutical.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT06821698 is a Phase 1 study that has completed, run by Kaken Pharmaceutical. The registered enrollment target is 38 participants.
The verdict
NCT06821698, a Phase 1 study, has completed, sponsored by Kaken Pharmaceutical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
Part 1 will evaluate the effects of KP-001 as an inhibitor of BCRP on the PK of rosuvastatin. In the Treatment Period 1, a single dose of rosuvastatin will be administered. In the Treatment Period 2, KP-001 will be administered once daily for 7 days and a single dose of rosuvastatin will be administered. Blood PK assessments of rosuvastatin will be performed until 48 hours postdose in each Treatment Period. Part 2 will evaluate the effects of KP-001 as an inducer and inhibitor of CYP1A2 on the PK of caffeine. A single dose of caffeine will be administered in the Treatment Period 1. KP-001 will be administered once daily for 10 days and a single dose of caffeine will be administered in the Treatment Period 2. Blood PK assessments of caffeine will be performed until 24 hours postdose in each Treatment Period. Part 3 will evaluate the effects of fluvoxamine as an inhibitor of CYP1A2 on the PK of KP-001. A single dose of KP-001 will be administered in the Treatment Period 1. Fluvoxamine will be administered as a single dose on the first day and then twice daily for 5 days and a single dose of KP-001 will be administered in the Treatment Period 2. Blood PK assessments of KP-001 will be performed until 48 hours postdose in each Treatment Period.
Interventions
- DRUG Caffeine citrate
- DRUG Fluvoxamine
- DRUG KP-001
- DRUG Rosuvastatin calcium10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2025-02-13 |
| Est. Completion | 2025-05-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06821698
The ClinicalTrials.gov registry entry for NCT06821698 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. The listed sponsor is Kaken Pharmaceutical, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Caffeine citrate is the first listed.
NCT06821698 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06821698 about?
NCT06821698 is a clinical study titled "To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers". Part 1 will evaluate the effects of KP-001 as an inhibitor of BCRP on the PK of rosuvastatin. In the Treatment Period 1, a single dose of rosuvastatin will be administered. In the Treatment Period 2, KP-001 will be administered once daily for 7 days and a single dose of rosuvastatin will be administ...
What is the current status of trial NCT06821698?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2025-02-13. Estimated completion is 2025-05-20.
What interventions are being tested in trial NCT06821698?
The interventions under investigation include: Caffeine citrate (DRUG), Fluvoxamine (DRUG), KP-001 (DRUG), Rosuvastatin calcium10mg (DRUG).
Who is sponsoring clinical trial NCT06821698?
This trial is sponsored by Kaken Pharmaceutical, which has 5 total clinical trials registered on ClinicalTrials.gov.
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