Compare the Pharmacokinetic of K-877 Controlled Release (CR) and Immediate Release (IR) Tablets in Healthy Adults.



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:12/20/2018
Start Date:October 5, 2018
End Date:November 20, 2018

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Single-Dose, Randomized, Open-Label, 4-Period, 4-Sequence Crossover Study of Three Prototypes of K-877 CR Tablet and Two K-877 Tablets Administered to Healthy Adult Volunteers

A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a
current normal K-877 tablet in healthy adult subjects.


Inclusion Criteria:

- Subject provides written informed consent before any study-specific evaluation is
performed.

- Subject is a healthy adult male or female aged 18 to 45 years, inclusive.

- Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.

- Subject meets all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

- Subject has clinically relevant abnormalities in the screening or check-in
assessments.

- Subject has a supine blood pressure (as measured at Screening during the collection of
vital signs) after resting for 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 (males) or 50
mm Hg diastolic (females). If the initial blood pressure is out of range, blood
pressure may be repeated after the subject has maintained a rested position in a quiet
environment for at least 10 minutes.

- Subject has a supine pulse rate (as measured at Screening during the collection of
vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats
per minute. If the initial pulse rate is out of range, the pulse rate may be repeated
after the subject has maintained a rested position in a quiet environment for at least
10 minutes.

- Subject does not meet any exclusion criteria outlined in the clinical study protocol.
We found this trial at
1
site
Austin, Texas 78744
?
mi
from
Austin, TX
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