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Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects

Sponsor
Akros Pharma Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01473069
Collaborator
(none)
41
Enrollment
1
Location
5
Arms
4
Duration (Months)
10.2
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 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).

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

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose 1 JTK-853, 400 mg ketoconazole

Drug: JTK-853, ketoconazole
JTK-853 Tablets or Placebo, twice a day for 14 days, JTK-853 and ketoconazole Tablets, 1 each on Day 15
Experimental: Dose 2 JTK-853

Drug: JTK-853 or Placebo
JTK-853 Tablets or Placebo, twice a day for 14 days
Experimental: Dose 3 JTK-853

Drug: JTK-853 or Placebo
JTK-853 Tablets or Placebo, twice a day for 14 days
Experimental: Dose 4 JTK-853

Drug: JTK-853 or Placebo
JTK-853 Tablets or Placebo, twice a day for 14 days
Placebo Comparator: Placebo

Drug: JTK-853 or Placebo
JTK-853 Tablets or Placebo, twice a day for 14 days

Outcome Measures

Primary Outcome Measures

  1. Number of subjects with adverse events [3 weeks]

Secondary Outcome Measures

  1. Maximum concentration (Cmax) of JTK-853 and metabolite M2 [3 weeks]

  2. Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2 [3 weeks]

  3. Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 [3 weeks]

  4. 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]

  5. Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration [3 weeks]

  6. Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration [3 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Body Mass Index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2

  2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit

  3. Female subjects must be either surgically sterile or postmenopausal

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 four weeks prior to Day -1

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:
NCT01473069
Other Study ID Numbers:
  • AK853-U-10-003
First Posted:
Nov 17, 2011
Last Update Posted:
Nov 21, 2011
Last Verified:
Nov 1, 2011
Keywords provided by Akros Pharma Inc.
JTK-853
Healthy subjects
Additional relevant MeSH terms:
Ketoconazole

Study Results

No Results Posted as of Nov 21, 2011