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Study of LC23-1306 in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT01526577
Recruitment Status : Unknown
Verified April 2012 by LG Life Sciences.
Recruitment status was:  Recruiting
First Posted : February 6, 2012
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: LC23-1306 Drug: placebo Drug: Ticagrelor Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
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
Study Start Date : March 2012
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Adverse events of LC23-1306 [ Time Frame: 7 days (plus or minus 1 day) ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01526577     History of Changes
Other Study ID Numbers: LG-PYCL001
LC23-1306 ( Other Identifier: LGLS )
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
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