This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM depot in healthy male volunteers. And, it is to predict the multiple-dose pharmacokinetics based on the single-dose pharmacokinetics of GB-5001 IM depot and the oral Aricept® (donepezil hydrochloride) tablet by PK modeling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Depending on the cohort, volume will be varied to administer.
A matched volume of placebo product will be administered to each subject in each cohort.
Single dose of Aricept tablet
Syneos Health
Québec, Canada
Incidence, severity, and dose-relationship of AEs
Time frame: Day 64
Vital signs
blood pressure \[BP\], respiratory rate \[RR\], heart rate \[HR\], and temperature
Time frame: Day 64
Electrocardiograms
Time frame: Day 64
Physical examination
Height, weight, and BMI will be recorded
Time frame: Day 64
Injection site assessments
Time frame: Day 64
Key PK parameters for single dose IM and Oral cohorts
AUCt: area under the plasma concentration vs time curve from time 0 to the time of the last measurable concentration
Time frame: Day 64
Key PK parameters for single dose IM and Oral cohorts
Cmax: maximum observed plasma concentration
Time frame: Day 64
Key PK parameters for single dose IM and Oral cohorts
tmax: time to maximum observed plasma concentration
Time frame: Day 64
Key PK parameters for single dose IM and Oral cohorts
λz: terminal elimination rate constant
Time frame: Day 64
Key PK parameters for single dose IM and Oral cohorts
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
t½: terminal elimination half-life
Time frame: Day 64