Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 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 sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic profile of JTK-853 and its metabolite M2 (one cohort only).

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of JTK-853 Administered for Two Weeks in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: JTK-853, ketoconazole
* Drug: JTK-853 or Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 four weeks prior to Day -1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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, 400 mg ketoconazole<br> | Drug: JTK-853, ketoconazole<br>* JTK-853 Tablets or Placebo, twice a day for 14 days, JTK-853 and ketoconazole Tablets, 1 each on Day 15<br>|
| Experimental: Dose 2 JTK-853<br> | Drug: JTK-853 or Placebo<br>* JTK-853 Tablets or Placebo, twice a day for 14 days<br>|
| Experimental: Dose 3 JTK-853<br> | Drug: JTK-853 or Placebo<br>* JTK-853 Tablets or Placebo, twice a day for 14 days<br>|
| Experimental: Dose 4 JTK-853<br> | Drug: JTK-853 or Placebo<br>* JTK-853 Tablets or Placebo, twice a day for 14 days<br>|
| Placebo Comparator: Placebo<br> | Drug: JTK-853 or Placebo<br>* JTK-853 Tablets or Placebo, twice a day for 14 days<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 |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) of JTK-853 and metabolite M2 |  | 3 weeks | 
| Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2 |  | 3 weeks | 
| Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 |  | 3 weeks | 
| Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2 |  | 3 weeks | 
| Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration |  | 3 weeks | 
| Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JTK-853, Healthy subjects