The Evaluation of Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers

Stroke Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396069
• Other study ID #: JP-NC-P1-14
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2015
• Last updated: June 23, 2016
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: March 2015
• 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

Double blind, randomized, placebo control, multiple dose, dose escalation study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• JPI-289
PARP-1 inhibitor
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-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
Primary	AUCt,ss and Cmax,ss(76h), Relative PAR level(73h,%)		96 hours, 73 hours	No
Secondary	Cav,ss		96 hours	No
Secondary	t1/2ß		96 hours	No
Secondary	Vd,ss		96 hours	No
Secondary	CL		96 hours	No