Skip to main content
OpenTrials
Completed

NCT Number: NCT02922465

Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 in Healthy Adult Volunteers

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cincinnati, Ohio, 45227, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

K-877

Drug

clopidogrel

Drug

Primary outcomes

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

    Time frame: Up to 72 hours after dosing

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

    Time frame: Up to 72 hours after dosing

Secondary outcomes

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

    Time frame: Through study completion up to 17 days.

    Subjects will be questioned in a general way by the investigator without specific symptoms suggested.

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 4, 2016
Registry last updated
Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.