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
  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:


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

ClinicalTrials.gov processed this record on July 31, 2014