Healthy
Conditions
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.
Interventions
DRUGK-877
DRUGClopidogrel
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of 20 participants with treatment emergent adverse events as assessed by the principle investigator | Through study completion up to 17 days. | Subjects will be questioned in a general way by the investigator without specific symptoms suggested. |
Countries
United States
Outcome results
None listed