Phase 1
N=113
Study of LC23-1306 in Healthy Male Subjects
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01526577 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Adverse Events of LC23-1306
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LC23-1306 (Drug); placebo (Drug); Ticagrelor (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- LG Life Sciences
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events of LC23-1306 |
— | — |
| PRIMARY Pharmacodynamic Measurement |
70; 30; 91.9 | — |
| PRIMARY Platelet Aggregation Test, Bleeding Test |
— | — |
| SECONDARY AUC |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01526577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.