NCT06821698

To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers

An Open-label Study to Determine the Effect of Oral Doses of KP-001 on Rosuvastatin and Caffeine PK After a Single Oral Administration and to Determine the Effect of Fluvoxamine on KP-001 PK After a Single Oral Administration in Volunteers

• 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

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.

Conditions

• Healty Volunteers

Interventions

Type	Name	Description
DRUG	KP-001	KP-001 100 mg dry syrup
DRUG	Rosuvastatin calcium10mg	A oral dose of 10 mg tablet
DRUG	Caffeine citrate	100 mg oral solution
DRUG	Fluvoxamine	50 mg tablet

Timeline

• Start date: 2025-02-13
• Primary completion: 2025-05-20
• Completion: 2025-05-20
• First posted: 2025-02-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study