Trial record 4 of 534 for:    Open Studies | "Platelet Aggregation Inhibitors"

Study of LC23-1306 in Healthy Male Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by LG Life Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01526577
First received: January 20, 2012
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: LC23-1306
Drug: placebo
Drug: Ticagrelor
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Blocked-randomized, Double-blind, Active and Placebo Controlled, Single and Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Adverse events of LC23-1306 [ Time Frame: 7 days (plus or minus 1 day) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: pre-dose, up to 3 days post-dose ] [ Designated as safety issue: No ]
  • AUC [ Time Frame: pre-dose, up to 3 days post-dose ] [ Designated as safety issue: No ]
  • Tmax [ Time Frame: pre-dose, up to 3 days post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LC23-1306
experimental drug
Drug: LC23-1306
LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg
Other Name: antiplatelet agent
Placebo Comparator: placebo
LC23-1306 placebo
Drug: placebo
LC23-1306 placebo
Active Comparator: Ticagrelor
active comparator
Drug: Ticagrelor
Ticagrelor 90mg

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male subjects between the ages of 20 and 50 years at screening
  2. Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI (kg/m2) = body weight (kg)/ {height (m)}2.
  3. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
  4. Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526577

Contacts
Contact: Kyung Sang Yu 82-2-2072-1920 ksyu@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Cinical Trial Center    82-2-2072-1681      
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01526577     History of Changes
Other Study ID Numbers: LG-PYCL001, LC23-1306
Study First Received: January 20, 2012
Last Updated: April 9, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by LG Life Sciences:
phase1
healthy subjects
antiplatelet agent

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ticagrelor
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014