Drug-Drug Interaction Study in Healthy Adult Volunteers | NCT02275975 | Trialant
CompletedInterventionalPhase 1Updated Oct 27, 2014
Drug-Drug Interaction Study in Healthy Adult Volunteers
ClinicalTrials.gov ID
NCT02275975
Lead Sponsor
Kowa Research Institute, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
20Actual
Last Update Posted
Oct 27, 2014Estimated
Start Date
Jul 2014
Primary Completion Date
Aug 2014Actual
Brief Summary
The purpose of this study is to assess the effects of fluconazole on the pharmacokinetics of K 877 in healthy adult subjects.
Healthy
K-877
Fluconazole
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.