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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01473069
First Posted: November 17, 2011
Last Update Posted: November 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Akros Pharma Inc.
November 9, 2011
November 17, 2011
November 21, 2011
March 2010
July 2010   (Final data collection date for primary outcome measure)
Number of subjects with adverse events [ Time Frame: 3 weeks ]
Same as current
Complete list of historical versions of study NCT01473069 on ClinicalTrials.gov Archive Site
  • Maximum concentration (Cmax) of JTK-853 and metabolite M2 [ Time Frame: 3 weeks ]
  • Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2 [ Time Frame: 3 weeks ]
  • Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 [ Time Frame: 3 weeks ]
  • 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: 3 weeks ]
  • Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration [ Time Frame: 3 weeks ]
  • Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration [ Time Frame: 3 weeks ]
  • Maximum concentration (Cmax), time to reach Cmax (tmax), area under the concentration-time curve (AUC) and elimination half life (t1/2) of JTK-853 and metabolite M2 [ Time Frame: 3 weeks ]
  • Area under the concentration-time curve (AUC) and maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration [ Time Frame: 3 weeks ]
Not Provided
Not Provided
 
Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects
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
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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • 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
  • Drug: JTK-853 or Placebo
    JTK-853 Tablets or Placebo, twice a day for 14 days
  • Experimental: Dose 1 JTK-853, 400 mg ketoconazole
    Intervention: Drug: JTK-853, ketoconazole
  • Experimental: Dose 2 JTK-853
    Intervention: Drug: JTK-853 or Placebo
  • Experimental: Dose 3 JTK-853
    Intervention: Drug: JTK-853 or Placebo
  • Experimental: Dose 4 JTK-853
    Intervention: Drug: JTK-853 or Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: JTK-853 or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01473069
AK853-U-10-003
No
Not Provided
Not Provided
Akros Pharma Inc.
Akros Pharma Inc.
Not Provided
Study Director: Shoji Hoshino, D.V.M Akros Pharma Inc.
Akros Pharma Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP