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KP-001

DRUG5 trials

Sponsors

Kaken Pharmaceutical

Conditions

CLOVES SyndromeHealthy AdultsHealthy Volunteers - Male and FemaleHealty VolunteersHepatic ImpairmentKlippel-Trenaunay SyndromeLymphatic MalformationsVenous Malformations

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
CompletedNCT06227832
Kaken PharmaceuticalHealthy Adults
Start: 2023-12-15End: 2024-07-31Updated: 2025-03-07
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001
CompletedNCT06619054
Kaken PharmaceuticalHealthy Adults, Hepatic Impairment
Start: 2024-10-24End: 2025-07-31Updated: 2025-10-31
A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults
CompletedNCT06649942
Kaken PharmaceuticalHealthy Volunteers - Male and Female
Start: 2024-10-01End: 2025-03-24Updated: 2025-09-17
To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers
CompletedNCT06821698
Kaken PharmaceuticalHealty Volunteers
Start: 2025-02-13End: 2025-05-20Updated: 2025-09-12

Phase 3

A Study to Investigate Efficacy and Safety of KP-001 Compared With Placebo in Patients Aged ≥2 Years With Common VM, Common LM, or KTS/CLOVES Syndrome
RecruitingNCT07285005
Kaken PharmaceuticalCLOVES Syndrome, Klippel-Trenaunay Syndrome, Lymphatic Malformations +1
Start: 2026-05-13End: 2028-02-01Target: 150Updated: 2026-07-22