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Completed

NCT Number: NCT02396069

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JPI-289

Drug

PARP-1 inhibitor

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: 96 hours, 73 hours

Secondary outcomes

  1. Cav,ss

    Time frame: 96 hours

  2. t1/2β

    Time frame: 96 hours

  3. Vd,ss

    Time frame: 96 hours

  4. CL

    Time frame: 96 hours

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 24, 2015
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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