Clinical trial NCT03351738: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
Official title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects With Stable Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stable Coronary Heart Disease
Keywords: Coronary heart disease
Pharmacokinetic
Pharmacodynamics
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2017-11-24
Enrollment: 133
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stable coronary heart disease prior to screening
* Currently receiving high intensity statin(s)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 (Baseline) through Day 241
measure: Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
timeFrame: Day 1 (Baseline) through Day 241
measure: Number of Participants With Clinically Important Changes in Vital Signs From Baseline
timeFrame: Day 1 (Baseline) through Day 241
measure: Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
timeFrame: Day 1 (Baseline) through Day 241
measure: Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
timeFrame: Day 1 (Baseline) through Day 241
Secondary outcomes:
measure: Change From Baseline in Apolipoprotein B
timeFrame: Day 1 (Baseline), and Days 31, 61, and 91
measure: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Day 1 (Baseline), and Days 31, 61, and 91
measure: Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884
timeFrame: Day 61 (pre-dose), and on Days 64, 68, 71, and 91
measure: Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose
timeFrame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
measure: Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose
timeFrame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
measure: Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884
timeFrame: Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: El Cajon
country: United States
facility: Research Site
state: California
city: Lincoln
country: United States
facility: Research Site
state: California
city: Northridge
country: United States
facility: Research Site
state: California
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Fleming Island
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Port Orange
country: United States
facility: Research Site
state: Florida
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Marion
country: United States
facility: Research Site
state: Ohio
city: Stow
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Rapid City
country: United States
facility: Research Site
state: South Dakota
city: Kingsport
country: United States
facility: Research Site
state: Tennessee
city: McAllen
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Jacksonville Center For Clinical Research
name: Michael J Koren, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruff CT, Koren MJ, Grimsby J, Rosenbaum AI, Tu X, Karathanasis SK, Falloon J, Hsia J, Guan Y, Conway J, Tsai LF, Hummer BT, Hirshberg B, Kuder JF, Murphy SA, George RT, Sabatine MS. LEGACY: Phase 2a Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of the Anti-EL (Endothelial Lipase) Antibody MEDI5884 in Patients With Stable Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2021 Dec;41(12):3005-3014. doi: 10.1161/ATVBAHA.120.315757. Epub 2021 Oct 28.