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

November 17, 2011 updated by: Akros Pharma Inc.

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).

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Austin, Texas, United States, 78744
        • PPD Phase I Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
JTK-853 Tablets or Placebo, twice a day for 14 days
Experimental: Dose 1 JTK-853, 400 mg 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
JTK-853 Tablets or Placebo, twice a day for 14 days
Experimental: Dose 3 JTK-853
JTK-853 Tablets or Placebo, twice a day for 14 days
Experimental: Dose 4 JTK-853
JTK-853 Tablets or Placebo, twice a day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with adverse events
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum concentration (Cmax) of JTK-853 and metabolite M2
Time Frame: 3 weeks
3 weeks
Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2
Time Frame: 3 weeks
3 weeks
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2
Time Frame: 3 weeks
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
3 weeks
Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration
Time Frame: 3 weeks
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
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Shoji Hoshino, D.V.M, Akros Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

November 21, 2011

Last Update Submitted That Met QC Criteria

November 17, 2011

Last Verified

November 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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