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Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers

Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04237597
Enrollment
20
Registered
2020-01-23
Start date
2019-12-17
Completion date
2020-03-04
Last updated
2020-09-22

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

Conditions

Healthy

Brief summary

A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.

Interventions

DRUGK-877

K-877 tablets

DRUGCSG452

CSG452 tablets

Sponsors

Kowa Research Institute, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Subject provides written informed consent before any study-specific evaluation is performed. * Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening. * Subject has a BMI of 18 to 30 kg/m2, inclusive, at Screening. * Subject meets all other inclusion criteria outlined in the clinical study protocol

Exclusion criteria

* Subject has clinically relevant abnormalities at Screening or at Check-in assessments. * Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug. * Subject does not meet any other

Design outcomes

Primary

MeasureTime frame
Area under the plasma concentration versus time curve (AUC)0 to 24 hours

Countries

United States

Outcome results

None listed

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