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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: K-877-ER; Drug: CSG452; Drug: K-001

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD - Austin Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Three period alternative intervention and fed/fasted sequence	Drug: K-877-ER; K-877-ER tablet; Drug: CSG452; CSG452 tablet; Drug: K-001; K-877-ER and CSG452 combination tablet
Experimental: Sequence B; Three period alternative intervention and fed/fasted sequence	Drug: K-877-ER; K-877-ER tablet; Drug: CSG452; CSG452 tablet; Drug: K-001; K-877-ER and CSG452 combination tablet
Experimental: Sequence C; Three period alternative intervention and fed/fasted sequence	Drug: K-877-ER; K-877-ER tablet; Drug: CSG452; CSG452 tablet; Drug: K-001; K-877-ER and CSG452 combination tablet
Experimental: Sequence D; Three period alternative intervention and fed/fasted sequence	Drug: K-877-ER; K-877-ER tablet; Drug: CSG452; CSG452 tablet; Drug: K-001; K-877-ER and CSG452 combination tablet
Experimental: Sequence E; Three period alternative intervention and fed/fasted sequence	Drug: K-877-ER; K-877-ER tablet; Drug: CSG452; CSG452 tablet; Drug: K-001; K-877-ER and CSG452 combination tablet
Experimental: Sequence F; Three period alternative intervention and fed/fasted sequence	Drug: K-877-ER; K-877-ER tablet; Drug: CSG452; CSG452 tablet; Drug: K-001; K-877-ER and CSG452 combination tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 5, 2023

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
• Other Study ID Numbers: K-001-1.02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No