- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01473069
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
Intervention / Treatment
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:
- Body Mass Index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2
- Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit
- Female subjects must be either surgically sterile or postmenopausal
Exclusion Criteria:
- History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
- 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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Ketoconazole
Other Study ID Numbers
- AK853-U-10-003
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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