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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05722262
• Other study ID #: K-001-1.02
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2023
• Est. completion date: April 5, 2023

Study information

• Verified date: June 2023
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 5, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Participant provides written informed consent before any study-specific evaluation is performed.

• Participant is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.

• Participant has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.

• Participant meet all other inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

• Participant has clinically significant abnormalities at Screening or at Check-in assessments, in the opinion of the investigator.

• Participant is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.

• Participant meets any other exclusion criteria outlined in the clinical study protocol.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• K-001
K-877-ER and CSG452 combination tablet
• K-877-ER
K-877-ER tablet
• CSG452
CSG452 tablet

Locations

Country	Name	City	State
United States	PPD - Austin Research Unit	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of K-877 and CSG452	Maximum observed plasma concentration (Cmax) of K-877 and CSG452	1 hour before dosing and at multiple time points (up to 48 hours) post dose
Primary	AUC0-t of K-877 and CSG452	Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)	1 hour before dosing and at multiple time points (up to 48 hours) post dose
Primary	AUC0-inf of K-877-and CSG452	Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).	1 hour before dosing and at multiple time points (up to 48 hours) post dose