A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
- Registration Number
- NCT03351738
- Lead Sponsor
- MedImmune LLC
- Brief Summary
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.
- Detailed Description
A Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Participants with Stable Coronary Heart Disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
- Diagnosis of stable coronary heart disease prior to screening
- Currently receiving high intensity statin(s)
- Unstable cardiovascular conditions
- Any planned arterial revascularizations
- Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density Lipoprotein-Cholesterol > 100 mg/dL
- Any disease or condition or laboratory value that would place the participant at an unacceptable risk.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MEDI5884 100 mg MEDI5884 Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61. MEDI5884 200 mg MEDI5884 Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61. MEDI5884 500 mg MEDI5884 Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61. Placebo Placebo Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61. MEDI5884 350 mg MEDI5884 Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61. MEDI5884 50 mg MEDI5884 Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Day 1 (Baseline) through Day 241 An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline Day 1 (Baseline) through Day 241 Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline Day 1 (Baseline) through Day 241 Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
Number of Participants With Clinically Important Changes in Vital Signs From Baseline Day 1 (Baseline) through Day 241 Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline Day 1 (Baseline) through Day 241 Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
- Secondary Outcome Measures
Name Time Method Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151 Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884 Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241 Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).
Change From Baseline in Apolipoprotein B Day 1 (Baseline), and Days 31, 61, and 91 Change from baseline in apolipoprotein B is reported.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) Day 1 (Baseline), and Days 31, 61, and 91 Percent change from baseline in HDL-C is reported.
Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151 Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.
Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884 Day 61 (pre-dose), and on Days 64, 68, 71, and 91 AUC30d after the last dose of MEDI5884 is reported.
Trial Locations
- Locations (1)
Research Site
🇺🇸San Antonio, Texas, United States