Study of LC23-1306 in Healthy Male Subjects

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526577
• Other study ID #: LG-PYCL001
• Secondary ID: LC23-1306
• Status: Completed
• Phase: Phase 1
• Start date: March 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: August 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• LC23-1306
LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg
• placebo
LC23-1306 placebo
• Ticagrelor
Ticagrelor 90mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events of LC23-1306		7 days (plus or minus 1 day)
Primary	Pharmacodynamic Measurement	Inhibition of platelet aggregation (IPA) was analized by the platelet aggregation test.; * Among the time points that platelet aggregation rate was meausred, the result only at 8h post dosing was provided in result section.	1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study
Primary	Platelet Aggregation Test, Bleeding Test		pre-dose, up to 1 day post-dose
Secondary	AUC		pre-dose, up to 3 days post-dose