NCT02396069

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 stroke

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

June 24, 2016

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

March 12, 2015

Last Update Submit

June 23, 2016

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%)

    96 hours, 73 hours

Secondary Outcomes (4)

  • Cav,ss

    96 hours

  • t1/2β

    96 hours

  • Vd,ss

    96 hours

  • CL

    96 hours

Study Arms (2)

JPI-289

EXPERIMENTAL

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

Drug: JPI-289

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

JPI-289DRUG

PARP-1 inhibitor

JPI-289
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \~55 years healthy male
  • BMI measurement 20kg/m²\~27kg/m²
  • ≤ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-Gu, 138-736, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

JPI-289

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hyeong-Seok Lim, M.D.,Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 24, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

June 24, 2016

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)