Pharmacokinetic Drug-Drug Interaction Study Between K-877... | NCT04237597

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

NCT04237597

Sponsor

Kowa Research Institute, Inc.

Status

Completed

Last Update Posted

Sep 22, 2020Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy

Interventions

K-877
CSG452

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2019Actual

Primary Completion Date

Jan 31, 2020Actual

Completion Date

Mar 4, 2020Actual

First Submitted Date

Jan 16, 2020

First Submission Date that Met QC Criteria

Jan 21, 2020

First Posted Date

Jan 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2020

Last Update Posted Date

Sep 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
K-877 & CSG452	Experimental	K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15	Drug: K-877 Drug: CSG452

Interventions

Name	Type	Description	Arm Group Labels	Other Names
K-877	Drug	K-877 tablets	K-877 & CSG452
CSG452

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PPD Development. LP		Austin	Texas	78744	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000603947	K-877 compound
C575086	6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided