A Phase 1 interventional study of KP-001 and Rosuvastatin calcium10mg in Healty Volunteers, sponsored by Kaken Pharmaceutical. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Kaken Pharmaceutical · Phase 1, Interventional, and Treatment
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.
Kaken Pharmaceutical is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(For Part 3 only) A participant who meets any of the following criteria based on the C-SSRS assessment at screening:
Drug: KP-001 · Drug: Rosuvastatin calcium10mg
Drug: KP-001 · Drug: Caffeine citrate
Drug: KP-001 · Drug: Fluvoxamine
KP-001 100 mg dry syrup
A oral dose of 10 mg tablet
100 mg oral solution
50 mg tablet
PK parameters of rosuvastatin in plasma: AUCinf
Time frame: 48hour
PK parameters of rosuvastatin in plasma: Cmax
Time frame: 48hour
PK parameters of caffeine in plasma: AUCinf
Time frame: 24hour
PK parameters of caffeine in plasma: Cmax
Time frame: 24hour
PK parameters of KP-001 in plasma: AUCinf
Time frame: 48hour
PK parameters of KP-001 in plasma: Cmax
Time frame: 48hour
PK parameters of rosuvastatin in plasma: AUClast
Time frame: 48hour
PK parameters of rosuvastatin in plasma: Tmax
Time frame: 48hour
PK parameters of rosuvastatin in plasma: t1/2
Time frame: 48hour
PK parameters of rosuvastatin in plasma: CLtot/F
Time frame: 48hour
PK parameters of rosuvastatin in plasma: Vz/F
Time frame: 48hour
PK parameters of caffeine in plasma: AUClast
Time frame: 24hour
PK parameters of caffeine in plasma: t1/2
Time frame: 24hour
PK parameters of caffeine in plasma: Tmax
Time frame: 24hour
PK parameters of caffeine in plasma: CLtot/F
Time frame: 24hour
PK parameters of caffeine in plasma: Vz/F
Time frame: 24hour
PK parameters of KP-001 in plasma: AUClast
Time frame: 48hour
PK parameters of KP-001 in plasma: Tmax
Time frame: 48hour
PK parameters of KP-001 in plasma: t1/2
Time frame: 48hour
PK parameters of KP-001 in plasma: Vz/F
Time frame: 48hour
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kaken Pharmaceutical