drugset
drugset / Trial / NCT06821698

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

NCT06821698 ↗

Phase 1 Completed 38 enrolled Kaken Pharmaceutical
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-02-13
Primary completion
2025-05-20
Completion
2025-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule 100 mg Oral
Subject Fluvoxamine Unknown 50 mg —
Subject KP-001 Unknown 100 mg Oral
Subject Rosuvastatin Small molecule 10 mg Oral

Indications

No indication recorded.