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Study of LC23-1306 in Healthy Male Subjects

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by LG Life Sciences.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
LG Life Sciences Identifier:
First received: January 20, 2012
Last updated: April 9, 2012
Last verified: April 2012
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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) ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: pre-dose, up to 3 days post-dose ]
  • AUC [ Time Frame: pre-dose, up to 3 days post-dose ]
  • Tmax [ Time Frame: pre-dose, up to 3 days post-dose ]

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


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01526577

Contact: Kyung Sang Yu 82-2-2072-1920

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

Responsible Party: LG Life Sciences Identifier: NCT01526577     History of Changes
Other Study ID Numbers: LG-PYCL001
LC23-1306 ( Other Identifier: LGLS )
Study First Received: January 20, 2012
Last Updated: April 9, 2012

Keywords provided by LG Life Sciences:
healthy subjects
antiplatelet agent

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on September 21, 2017