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

Sponsor
Akros Pharma Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01475981
Collaborator
(none)
70
Enrollment
1
Location
11
Arms
3
Duration (Months)
23.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: JTK-853 or Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Number of subjects with adverse events [1 week]

  2. Maximum concentration (Cmax) of JTK-853 and metabolite M2 [1 week]

  3. Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2 [1 week]

  4. 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]

  5. Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2 [1 week]

  6. 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]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01475981
Other Study ID Numbers:
  • AK853-U-09-001
First Posted:
Nov 22, 2011
Last Update Posted:
Nov 22, 2011
Last Verified:
Nov 1, 2011
Keywords provided by Akros Pharma Inc.
JTK-853
single dose

Study Results

No Results Posted as of Nov 22, 2011