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

Sponsor

Kowa Research Institute, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05722262

Collaborator

(none)

Enrollment

Arms

1.3

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: K-001 Drug: K-877-ER Drug: CSG452	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Randomized, open-label, six-sequence, three-period, crossover studyRandomized, open-label, six-sequence, three-period, crossover study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Feb 24, 2023

Anticipated Primary Completion Date :

Apr 5, 2023

Anticipated Study Completion Date :

Apr 5, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kowa Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kowa Research Institute, Inc.

ClinicalTrials.gov Identifier:

NCT05722262

Other Study ID Numbers:

K-001-1.02

First Posted:

Feb 10, 2023

Last Update Posted:

Feb 10, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol

Study Results

No Results Posted as of Feb 10, 2023