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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
Hepatitis
10019654
10047438
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
NameTimeMethod
<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
NameTimeMethod
<p>Nvt</p><br>
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