NCT02922465

Brief Summary

The primary objective of this study is to assess the effects of clopidogrel on the PK of K-877 in healthy adult subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

1 month

First QC Date

September 15, 2016

Last Update Submit

December 20, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Plasma exposure of K-877 by measuring Cmax when administered alone or with Clopidogrel

    Up to 72 hours after dosing

  • Plasma exposure of K-877 by measuring AUC when administered alone or with Clopidogrel

    Up to 72 hours after dosing

Secondary Outcomes (1)

  • Evaluation of 20 participants with treatment emergent adverse events as assessed by the principle investigator

    Through study completion up to 17 days.

Study Arms (1)

K-877 & Clopidogrel

EXPERIMENTAL

K-877 \& Clopidogrel orally

Drug: K-877Drug: Clopidogrel

Interventions

K-877DRUG
K-877 & Clopidogrel
ClopidogrelDRUG
K-877 & Clopidogrel

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;
  • Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges, or results that do not show clinically significant abnormalities, as judged by the Investigator at screening and check-in;

You may not qualify if:

  • Subject is a woman who is pregnant or breastfeeding;
  • Subject has clinically significant abnormalities in the screening or check-in assessments;
  • Subject has current or history of clinically significant coagulation, bleeding, or platelet disorders;
  • Subject or a family member of the subject has a history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, including aneurysms;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Interventions

K-877 compoundClopidogrel

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

October 4, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

December 21, 2016

Record last verified: 2016-12

Locations

US(1)