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

NCT05722262 | Completed Phase 1 FDA Drug

• 1 other identifier: K-001-1.02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (6)

Sequence A

EXPERIMENTAL

Three period alternative intervention and fed/fasted sequence

Drug: K-001; Drug: K-877-ER; Drug: CSG452

Sequence B

EXPERIMENTAL

Three period alternative intervention and fed/fasted sequence

Drug: K-001; Drug: K-877-ER; Drug: CSG452

Sequence C

EXPERIMENTAL

Three period alternative intervention and fed/fasted sequence

Drug: K-001; Drug: K-877-ER; Drug: CSG452

Sequence D

EXPERIMENTAL

Three period alternative intervention and fed/fasted sequence

Drug: K-001; Drug: K-877-ER; Drug: CSG452

Sequence E

EXPERIMENTAL

Three period alternative intervention and fed/fasted sequence

Drug: K-001; Drug: K-877-ER; Drug: CSG452

Sequence F

EXPERIMENTAL

Three period alternative intervention and fed/fasted sequence

Drug: K-001; Drug: K-877-ER; Drug: CSG452

Interventions

K-001 DRUG

K-877-ER and CSG452 combination tablet

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

K-877-ER DRUG

K-877-ER tablet

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

CSG452 DRUG

CSG452 tablet

Sequence A; Sequence B; Sequence C; Sequence D; Sequence E; Sequence F

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

PPD - Austin Research Unit

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, six-sequence, three-period, crossover study

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: February 24, 2023
• Primary Completion: April 1, 2023
• Study Completion: April 5, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Locations

US (1)