The Evaluation of Safety, Tolerability and Pharmacokinetics of Stroke Targeting Drug in Healthy Volunteers

Stroke Clinical Trial

— JPI-289  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983358
• Other study ID #: JP-NC-P1-13
• Status: Completed
• Phase: Phase 1
• First received: November 4, 2013
• Last updated: June 23, 2016
• Start date: November 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• JPI-289
PARP-1 inhibitor

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Song-Pa Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference of PAR level in PBMC between JPI-289 group and placebo group	-Blood 0h(pre-dose),1h, 4h, 7h, 24h, 48h	0h(pre-dose)~48h, 6 points	Yes
Primary	Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group		-21d~9d	Yes
Secondary	Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group	Blood; Urine 0h(pre-dose), 5min, 10min, 20min, 30min(before termination of infusion JPI-289), 45min, 1h, 2h, 4h, 8h, 12h, 24h, 48h	0h~48h , 15 points	Yes