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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05722262

Enrollment

Registered

2023-02-10

Start date

2023-02-24

Completion date

2023-04-05

Last updated

2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGK-001

K-877-ER and CSG452 combination tablet

DRUGK-877-ER

K-877-ER tablet

DRUGCSG452

CSG452 tablet

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026