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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JTK-853 or Placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD, Phase I Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Body mass index (BMI) of 18-30 kg/m2 (inclusive)
2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit

Exclusion Criteria:

1. History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
2. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

11

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Akros Pharma Inc.
• Investigators: Study Director: Shoji Hoshino, D.V.M, Akros Pharma Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: November 17, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 22, 2011
• Last Update Submitted That Met QC Criteria: November 17, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: single dose; JTK-853
• Other Study ID Numbers: AK853-U-09-001