A phase 1, randomized, double-blind, placebo-controlled, ascending dose study evaluating the safety, tolerability and pharmacokinetics of JTK-652 administered for two weeks in healthy male subjects
Completed
- Conditions
- Hepatitis1001965410047438
- Registration Number
- NL-OMON31189
- Lead Sponsor
- Japan Tobacco, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Man
Age : 18-55 yr
BMI : 19-28 kg/m2, inclusive
Exclusion Criteria
Current abuse of alcohol or/and drugs
Clinical significant indications in man's medical history
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety : AE's, clinical laboratory parameters, vital signs, ECG and physical<br /><br>examination<br /><br>Pharmacokinetics : plasma JTK-652 concentrations, pharmacokinetics parameters</p><br>
- Secondary Outcome Measures
Name Time Method <p>Nvt</p><br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms and drug targets does JTK-652 modulate in the NL-OMON31189 Hepatitis trial?
How does JTK-652's efficacy compare to standard-of-care antivirals in Hepatitis B or C patients?
What biomarkers are being explored for patient selection in JTK-652 trials targeting Hepatitis subtypes?
What adverse events were observed in the JTK-652 ascending dose study NL-OMON31189 and their management?
Are there combination therapies or competitor drugs to JTK-652 for Hepatitis treatment by Japan Tobacco, Inc.?