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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014