Status:
COMPLETED
Study to Assess the Food Effect of K-877 in Healthy Adult Volunteers
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Study is to assess the effects of food on the Pharmacokinetics(PK) of single-dose administration of K-877 in healthy adult volunteers.
Eligibility Criteria
Inclusion
- 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 inclusion criteria outlined in the clinical study protocol
Exclusion
- Subject is a woman who is pregnant or breastfeeding;
- Subject has clinically significant abnormalities in the screening or check-in assessments;
- Subject has received an investigational drug within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug
- Subject does not meet any other exclusion criteria outlined in clinical study protocol.
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04742218
Start Date
January 13 2021
End Date
April 11 2021
Last Update
August 9 2021
Active Locations (1)
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1
PPD Development, LP
Austin, Texas, United States, 78744