Clinical trial NCT01983358: The Evaluation of Safety, Tolerability and Pharmacokinetics of Stroke Targeting Drug in Healthy Volunteers
Official title: A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled,Single Dose, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of JPI-289 in Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: PARP-1 inhibitor
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-14
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in healthy male subjects.

Detailed description: tPA treatment should be used within 3 hours after stroke onset for treating efficacy, but JPI-289 treatment(PARP-1 inhibitor) showed treating efficacy more than 10 hours after stroke onset. PARP-1 inhibitor add-on therapy of tPA will be very useful to prevent social, economic loss from physical, and mental disable by stroke.

This clinical trial progresses to explore safety, tolerability, pharmacokinetic/pharmacodynamic properties of JPI-289 by single dose escalation(7cohort). Investigational product medication of each level within 4 weeks evaluate safety and tolerability of patient through Data Safety Monitoring Board(DSMB) which is composed of more than 3 experts except principal investigator until the last visit. In each level 6 patients for investigational product and 2 patients for placebo will be allocated respectively in double blind manner.

Eligibility criteria: 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 from 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

Primary outcomes:
measure: Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group
timeFrame: -21d~9d
Secondary outcomes:
measure: Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group
timeFrame: 0h~48h , 15 points
Other outcomes:
measure: Difference of PAR level in PBMC between JPI-289 group and placebo group
timeFrame: 0h(pre-dose)~48h, 6 points
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Song-Pa Gu
Study officials:
affiliation: AIDS Malignancy Consortium
name: HyeongSeok Lim, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: