Study of LC23-1306 in Healthy Male Subjects

This study is currently recruiting participants.

Verified April 2012 by LG Life Sciences

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

History of Changes

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:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Ticagrelor

U.S. FDA Resources

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:

Healthy male subjects between the ages of 20 and 50 years at screening
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.
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.
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 May 22, 2013

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