Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects
- Registration Number
- NCT01475981
- Lead Sponsor
- Akros Pharma Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 70
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 2 JTK-853 (fasted condition) JTK-853 or Placebo - Dose 3 JTK-853 (fasted condition) JTK-853 or Placebo - Dose 2 JTK-853 (fed condition) JTK-853 or Placebo - Dose 4 JTK-853 (fed condition) JTK-853 or Placebo - Dose 6 JTK-853 (fed condition) JTK-853 or Placebo - Dose 7 JTK-853 (fed condition) JTK-853 or Placebo - Dose 5 JTK-853 (high-fat fed condition) JTK-853 or Placebo - Dose 5 JTK-853 (fed condition) JTK-853 or Placebo - Dose 1 JTK-853 (fasted condition) JTK-853 or Placebo - Dose 3 JTK-853 (fed condition) JTK-853 or Placebo - Placebo JTK-853 or Placebo -
- Primary Outcome Measures
Name Time Method Number of subjects with adverse events 1 week Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2 1 week Maximum concentration (Cmax) of JTK-853 and metabolite M2 1 week Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2 1 week Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2 1 week Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2 1 week
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PPD, Phase I Clinic
🇺🇸Austin, Texas, United States