Status:
COMPLETED
Drug-Drug Interaction Study in Healthy Adult Volunteers
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics of K-877 in healthy adult subjects.
Eligibility Criteria
Inclusion
- Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.
Exclusion
- Subject has clinically relevant abnormalities in the screening or check in assessments.
- Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
- Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02275988
Start Date
June 1 2014
Last Update
October 27 2014
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78744