A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ALTERNATING PANEL, SINGLE ASCENDING DOSE STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF JTK-656 AND THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF JTK-656 IN HEALTHY MALE SUBJECTS
Completed
- Conditions
- immune deficiency infections10021460
- Registration Number
- NL-OMON32420
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Healthy volunteers
Male
18 and 55 years of age
Body Mass Index: 19 - 28 kg/m2, inclusive, at the screening visit
Exclusion Criteria
Clinically relevant medical history
Hypersensitivity to any component of the JTK-656 formulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Criteria for evaluation<br /><br><br /><br>Pharmacokinetics :Plasma JTK-656<br /><br>concentrations, PK parameters<br /><br>Safety :AEs, vital signs,<br /><br>ECG-parameters, laboratory parameters, physical examination and weight<br /><br>Exploratory lipid profile assessments :HDL2-cholesterol and HDL3-cholesterol<br /><br><br /><br>Statistical methods<br /><br><br /><br>Pharmacokinetic parameters :Analysis of variance (ANOVA) on<br /><br>Cmax and AUC to explore the food effect, statistical analysis on<br /><br>dose-normalized Cmax, AUClast and AUCinf to assess dose proportionality, other<br /><br>parameters descriptive statistics<br /><br>Safety parameters :Descriptive statistics,<br /><br>frequency tables<br /><br>Exploratory lipid profile parameters :Descriptive statistics</p><br>
- Secondary Outcome Measures
Name Time Method <p>N.v.t.</p><br>