Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects
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
1 other identifier
interventional
41
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 9, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedNovember 21, 2011
November 1, 2011
4 months
November 9, 2011
November 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with adverse events
3 weeks
Secondary Outcomes (6)
Maximum concentration (Cmax) of JTK-853 and metabolite M2
3 weeks
Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2
3 weeks
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2
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
3 weeks
Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration
3 weeks
- +1 more secondary outcomes
Study Arms (5)
Dose 1 JTK-853, 400 mg ketoconazole
EXPERIMENTALDose 2 JTK-853
EXPERIMENTALDose 3 JTK-853
EXPERIMENTALDose 4 JTK-853
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
JTK-853 Tablets or Placebo, twice a day for 14 days, JTK-853 and ketoconazole Tablets, 1 each on Day 15
JTK-853 Tablets or Placebo, twice a day for 14 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PPD Phase I Clinic
Austin, Texas, 78744, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shoji Hoshino, D.V.M
Akros Pharma Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2011
First Posted
November 17, 2011
Study Start
March 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
November 21, 2011
Record last verified: 2011-11