Cincinnati, Ohio, 45227, United States
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.
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
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
Drugclopidogrel
DrugPrimary outcomes
-
Plasma exposure of K-877 by measuring Cmax when administered alone or with Clopidogrel
Time frame: Up to 72 hours after dosing
-
Plasma exposure of K-877 by measuring AUC when administered alone or with Clopidogrel
Time frame: Up to 72 hours after dosing
Secondary outcomes
-
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.
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