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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01475981
First received: November 9, 2011
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: JTK-853 or Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) of JTK-853 and metabolite M2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: JTK-853 or Placebo
Tablets, single dose, fasted, fed or high-fat fed condition

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475981

Locations
United States, Texas
PPD, Phase I Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Akros Pharma Inc.
Investigators
Study Director: Shoji Hoshino, D.V.M Akros Pharma Inc.
  More Information

No publications provided

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT01475981     History of Changes
Other Study ID Numbers: AK853-U-09-001
Study First Received: November 9, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Akros Pharma Inc.:
JTK-853
single dose

ClinicalTrials.gov processed this record on May 22, 2013