Drug-Drug Interaction Study in Healthy Adult Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:4/21/2016
Start Date:September 2014
End Date:May 2015

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The purpose of this study is to assess the effects of rifampin on the pharmacokinetics of
K-877 in healthy adult volunteers.


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.
We found this trial at
1
site
PPD
Austin, Texas 78744
?
mi
from
Austin, TX
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