Randomized,Double-blind,Placebo-controlled,Ascending Dose Part Evaluating Safety,Tolerability and Pharmacokinetics (PK) of JTK-853 (Fasted/Fed) and Randomized,Open-label,Crossover Part Evaluating Food Effect on PK in Healthy Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Akros Pharma Inc.
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Number of subjects with adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Dose 1 JTK-853 (fasted condition)
Intervention: JTK-853 or Placebo (Drug)
Dose 2 JTK-853 (fasted condition)
Intervention: JTK-853 or Placebo (Drug)
Dose 3 JTK-853 (fasted condition)
Intervention: JTK-853 or Placebo (Drug)
Dose 2 JTK-853 (fed condition)
Intervention: JTK-853 or Placebo (Drug)
Dose 3 JTK-853 (fed condition)
Intervention: JTK-853 or Placebo (Drug)
Dose 4 JTK-853 (fed condition)
Intervention: JTK-853 or Placebo (Drug)
Dose 5 JTK-853 (fed condition)
Intervention: JTK-853 or Placebo (Drug)
Dose 6 JTK-853 (fed condition)
Intervention: JTK-853 or Placebo (Drug)
Dose 7 JTK-853 (fed condition)
Intervention: JTK-853 or Placebo (Drug)
Dose 5 JTK-853 (high-fat fed condition)
Intervention: JTK-853 or Placebo (Drug)
Placebo
Intervention: JTK-853 or Placebo (Drug)
Outcomes
Primary Outcomes
Number of subjects with adverse events
Time Frame: 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
Time Frame: 1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M2
Time Frame: 1 week
Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2
Time Frame: 1 week
Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2
Time Frame: 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
Time Frame: 1 week
Secondary Outcomes
No secondary outcomes reported