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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:
Information provided by (Responsible Party):
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01473069
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 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 Intervention Phase
Healthy
 Drug: JTK-853, ketoconazole
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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum concentration (Cmax) of JTK-853 and metabolite M2 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 [ Time Frame: 3 weeks ] [ 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: 3 weeks ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473069

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: NCT01473069     History of Changes
Other Study ID Numbers: AK853-U-10-003
Study First Received: November 9, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Akros Pharma Inc.:
JTK-853
Healthy subjects

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013