Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects
Lead Sponsor:
Akros Pharma Inc.
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.
Eligibility Criteria
Inclusion
- Body mass index (BMI) of 18-30 kg/m2 (inclusive)
- Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit
Exclusion
- History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
- Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen), within 4 weeks prior to the Day before dosing
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01475981
Start Date
January 1 2010
End Date
April 1 2010
Last Update
November 22 2011
Active Locations (1)
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1
PPD, Phase I Clinic
Austin, Texas, United States, 78744