Drug-Drug Interaction Study in Healthy Adult Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

The primary objective of this study is to assess the effects of cyclosporine on the pharmacokinetics of K-877 in healthy adult subjects.

Key facts

Study ID

NCT02276001

Run by

Kowa Research Institute, Inc.

People needed

20

Starts

2014-06-01

Last updated by the study team

2014-10-27

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD — Austin, Texas, United States

Full record on ClinicalTrials.gov

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