Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: JTK-853 or Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 JTK-853 (fasted condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Experimental: Dose 2 JTK-853 (fasted condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Experimental: Dose 3 JTK-853 (fasted condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Experimental: Dose 2 JTK-853 (fed condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Experimental: Dose 3 JTK-853 (fed condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Experimental: Dose 4 JTK-853 (fed condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Experimental: Dose 5 JTK-853 (fed condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Experimental: Dose 6 JTK-853 (fed condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Experimental: Dose 7 JTK-853 (fed condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Experimental: Dose 5 JTK-853 (high-fat fed condition)<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|
| Placebo Comparator: Placebo<br> | Drug: JTK-853 or Placebo<br>* Tablets, single dose, fasted, fed or high-fat fed condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | 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 the last quantifiable time point (AUClast) 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JTK-853, single dose