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

September 21, 2020 updated by: Kowa Research Institute, Inc.
A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • PPD Development. LP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 exclusion criteria outlined in the clinical study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: K-877 & CSG452
K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15
Drug: K-877
K-877 tablets
Drug: CSG452
CSG452 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC)
Time Frame: 0 to 24 hours
0 to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 17, 2019

Primary Completion (ACTUAL)

January 31, 2020

Study Completion (ACTUAL)

March 4, 2020

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 21, 2020

First Posted (ACTUAL)

January 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-001-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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