Status:
TERMINATED
Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects
Lead Sponsor:
Akros Pharma Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to determine the safety, tolerability and pharmacokinetics of sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also to determine the...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2
- Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit
- Female subjects must be either surgically sterile or postmenopausal
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 four weeks prior to Day -1
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01473069
Start Date
March 1 2010
End Date
July 1 2010
Last Update
November 21 2011
Active Locations (1)
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1
PPD Phase I Clinic
Austin, Texas, United States, 78744