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

NCT ID: NCT02396069

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-08-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JPI-289

Each cohort, volunteers will be infused JPI-289 for 60 min. (6 volunteers per each cohort, total 3 cohort)

Group Type: EXPERIMENTAL

JPI-289

Intervention Type: DRUG

PARP-1 inhibitor

Placebo

Each cohort, volunteer will be infused placebo for 60 min. (2 volunteers per each cohort, total 3 cohort)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

JPI-289

PARP-1 inhibitor

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyeong-Seok Lim, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Countries

South Korea

Other Identifiers

JP-NC-P1-14

Identifier Type: -

Identifier Source: org_study_id