Expired Study
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Austin, Texas 78744


Purpose:

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.


Criteria:

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.


NCT ID:

NCT03702673


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Austin, Texas 78744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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