A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease

Stable Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351738
• Other study ID #: D7870C00002
• Status: Completed
• Phase: Phase 2
• Start date: December 13, 2017
• Est. completion date: November 9, 2018

Study information

• Verified date: March 2020
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.

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 information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Stable Coronary Heart Disease

Intervention

Drug:
• MEDI5884
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
• Placebo
Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.

Locations

Country	Name	City	State
United States	Research Site	Anniston	Alabama
United States	Research Site	Cincinnati	Ohio
United States	Research Site	El Cajon	California
United States	Research Site	Evanston	Illinois
United States	Research Site	Fargo	North Dakota
United States	Research Site	Fleming Island	Florida
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kingsport	Tennessee
United States	Research Site	Lincoln	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Marion	Ohio
United States	Research Site	McAllen	Texas
United States	Research Site	Northridge	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Port Orange	Florida
United States	Research Site	Rapid City	South Dakota
United States	Research Site	San Antonio	Texas
United States	Research Site	Savannah	Georgia
United States	Research Site	Stow	Ohio
United States	Research Site	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	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.	Day 1 (Baseline) through Day 241
Primary	Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline	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.	Day 1 (Baseline) through Day 241
Primary	Number of Participants With Clinically Important Changes in Vital Signs From Baseline	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.	Day 1 (Baseline) through Day 241
Primary	Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline	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.	Day 1 (Baseline) through Day 241
Primary	Number of Participants With Clinically Important Changes in Physical Examinations From Baseline	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.	Day 1 (Baseline) through Day 241
Secondary	Change From Baseline in Apolipoprotein B	Change from baseline in apolipoprotein B is reported.	Day 1 (Baseline), and Days 31, 61, and 91
Secondary	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)	Percent change from baseline in HDL-C is reported.	Day 1 (Baseline), and Days 31, 61, and 91
Secondary	Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884	AUC30d after the last dose of MEDI5884 is reported.	Day 61 (pre-dose), and on Days 64, 68, 71, and 91
Secondary	Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose	Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.	Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Secondary	Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose	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.	Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Secondary	Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884	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).	Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241

External Links

•   D7870C00002 Clinical Protocol Redacted
•   D7870C00002 Statistical Analysis Plan Redacted