This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects. The study will include single ascending dose (SAD) in healthy young and elderly subjects.
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects and to perform a preliminary assessment of the effect of food on safety and PK parameters of J147. The study will include single ascending dose (SAD) in healthy young and elderly subjects. Approximately 64 subjects may be included in the study, with an additional 24 to be added depending on the emerging data. Six cohorts of 8 healthy young male subjects and 2 cohorts of 8 healthy elderly male and female subjects are planned. Depending on emerging safety, tolerability and PK data, 2 additional cohorts of 8 healthy young male subjects in each cohort and 1 additional cohort of 8 elderly male and female subjects may be enrolled. In each cohort, 6 subjects will be randomized to receive a single dose of J147 orally and 2 subjects will be randomized to receive a matching dose of placebo. All cohorts will consist of 2 sentinel subjects of whom 1 subject will receive J147 and 1 subject will receive matching placebo. The remaining 6 subjects of whom 5 subjects will receive J147 and 1 subject will receive matching placebo will be dosed at least 24 hours following the sentinel subjects. Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States
Incidence of treatment-emergent adverse events
Nature, frequency and severity of adverse events
Time frame: from pre-dose to 7+/-2 days post dose
Number of subjects with abnormal electrocardiogram
12-lead electrocardiogram measurement
Time frame: from pre-dose to 7+/-2 days post dose
Incidence of clinically significant changes in serum biomarker levels in a standard serum chemistry panel
Changes in standard serum chemistry measures will be assessed.
Time frame: from pre-dose to 7+/-2 days post dose
Incidence of clinically significant changes in hematological biomarker levels in a standard hematology panel
Changes in standard hematology measures will be assessed.
Time frame: from pre-dose to 7+/-2 days post dose
Incidence of clinically significant changes in urine biomarker levels in a standard urinalysis panel
Changes in standard urinalysis measures will be assessed.
Time frame: from pre-dose to 7+/-2 days post dose
Number of patients exhibiting changes in standard Physical Examination results
Time frame: from pre-dose to 7+/-2 days post dose
Number of patients exhibiting changes in standard Neurological Examination results
Time frame: from pre-dose to 7+/-2 days post dose
Maximum plasma concentration (Cmax)
Time frame: 0-48 hours post dose
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Time to Cmax (Tmax)
Time frame: 0-48 hours post dose
Area under the plasma concentration vs. time curve (AUC)
Time frame: 0-48 hours post dose
Terminal rate constant
Time frame: 0-48 hours post dose
Terminal half-life (t1/2)
Time frame: 0-48 hours post dose
Apparent plasma clearance (CL/F)
Time frame: 0-48 hours post dose
Renal clearance (CLr)
Time frame: 0-48 hours post dose