- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475981
Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects
November 17, 2011 updated by: Akros Pharma Inc.
Randomized,Double-blind,Placebo-controlled,Ascending Dose Part Evaluating Safety,Tolerability and Pharmacokinetics (PK) of JTK-853 (Fasted/Fed) and Randomized,Open-label,Crossover Part Evaluating Food Effect on PK in Healthy Male Subjects
The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.
Study Overview
Study Type
Interventional
Enrollment (Actual)
70
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Body mass index (BMI) of 18-30 kg/m2 (inclusive)
- Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit
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 4 weeks prior to the Day before dosing
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
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 1 JTK-853 (fasted condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 2 JTK-853 (fasted condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 3 JTK-853 (fasted condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 2 JTK-853 (fed condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 3 JTK-853 (fed condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 4 JTK-853 (fed condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 5 JTK-853 (fed condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 6 JTK-853 (fed condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 7 JTK-853 (fed condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
Experimental: Dose 5 JTK-853 (high-fat fed condition)
|
Tablets, single dose, fasted, fed or high-fat fed condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects with adverse events
Time Frame: 1 week
|
1 week
|
Maximum concentration (Cmax) of JTK-853 and metabolite M2
Time Frame: 1 week
|
1 week
|
Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2
Time Frame: 1 week
|
1 week
|
Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2
Time Frame: 1 week
|
1 week
|
Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2
Time Frame: 1 week
|
1 week
|
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: 1 week
|
1 week
|
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
January 1, 2010
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
November 9, 2011
First Submitted That Met QC Criteria
November 17, 2011
First Posted (Estimate)
November 22, 2011
Study Record Updates
Last Update Posted (Estimate)
November 22, 2011
Last Update Submitted That Met QC Criteria
November 17, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AK853-U-09-001
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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