Stroke
Conditions
Brief summary
Double blind, randomized, placebo control, multiple dose, dose escalation study
Detailed description
A phase I clinical study, randomized, double-blind, placebo-controlled, multiple doses, dose escalation study of the safety, tolerability and pharmacokinetics/pharmacodynamics of JPI-289 in healthy male volunteers.
Interventions
DRUGJPI-289
PARP-1 inhibitor
DRUGPlacebo
Placebo
Sponsors
Jeil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 19\ 55 years healthy male * BMI measurement 20kg/m²\ 27kg/m² * 90 ≤ SBP\<140(mmHg) 60 ≤ DBP\<100(mmHg) 45 ≤ Pulse rate\<100(bpm) * Signed the informed consent form to participate voluntarily and to comply with the trial requirements * For a follow-up visit and during the study period, blood samples and availability
Exclusion criteria
* History of clinically significant hepatic, gastrointestinal, pulmonary, musculoskeletal, endocrine, psychiatric, hematooncologic, cardiovascular (Specially asthma, obstructive pulmonary disease, peptic ulcer) * History of skin disease of graft affecting absorption of the drug * History of drug abuse * Positive urine drug screening * Administrated investigational product in a previous clinical trial within 60 days of the screening test * Donated blood within 60 days prior to screening test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%) | 96 hours, 73 hours |
Secondary
| Measure | Time frame |
|---|---|
| t1/2β | 96 hours |
| Vd,ss | 96 hours |
| CL | 96 hours |
| Cav,ss | 96 hours |
Countries
South Korea
Outcome results
None listed