NCT05722262

Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452

A Randomized, Open-Label, Six-Sequence, Three-Period Crossover Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER Plus CSG452 in Healthy Adult Volunteers, and to Characterize the Food Effect on the Pharmacokinetics of K-001

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	K-001	K-877-ER and CSG452 combination tablet
DRUG	K-877-ER	K-877-ER tablet
DRUG	CSG452	CSG452 tablet

Timeline

• Start date: 2023-02-24
• Primary completion: 2023-04-01
• Completion: 2023-04-05
• First posted: 2023-02-10
• Last updated: 2023-06-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study