Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

An Intravenous, Open-label, Single-dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of rhLCAT in Subjects With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554800
• Other study ID #: ACP 501-01
• Secondary ID: 12-H-0092
• Status: Completed
• Phase: Phase 1
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose will be escalated by cohort.

Description:

After signing informed consent, subjects entered into the trial will be followed for up to 8 weeks which includes: up to 4 weeks screening, entry criteria assessments on Day 0 and single-dose IV infusion on Day 1, and 4 weeks of follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• A history of stable documented CAD

• Currently non-smoking males and females ages 30 to 85 years inclusive.

o Female subjects of child-bearing potential (neither pregnant nor breast-feeding) must be using adequate birth control during study conduct.

• Chronic concomitant medications must be stable for at least 2 months prior to screening

• HDL-C < 50 mg/dL for men and < 55 mg/dL for women

• Body Mass Index (BMI) of approximately 18 to 35 kg/m^2; and a total body weight >= 50 kg (110 lbs) and <= 110 kg (approximately 242 lbs)

Exclusion Criteria:

• Myocardial infarction, stroke, or coronary intervention/revascularization procedure within 6 months prior to dosing.

• Chronic heart failure (> New York Heart Association (NYHA) Functional Classification II).

• Ventricular tachyarrhythmias.

• Uncontrolled Type 2 (HbA1c > 8.5%) or Type 1 diabetes mellitus.

• History of febrile illness within 5 days prior to dosing.

• History of regular alcohol consumption exceeding 10 drinks per week.

• 12-lead ECG demonstrating QTc > 500 msec at screening.

• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• ACP-501
A single dose infusion

Locations

Country	Name	City	State
United States	Cardiovascular and Pulmonary Branch (CPB) of NIH	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of Participants Experience with Safety and Tolerability	Safety and tolerability of a single dose of ACP-501 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examination, and electrocardiograms (ECGs).	Day 1 to Day 28
Secondary	Pharmacokinetic profile		Hours 0, 1, 6, 12, 24, 48, 72, 96, 168
Secondary	Change in High-Density Lipoprotein-Cholesterol (HDL-C) value following a single dose		Hours 0, 1, 6, 12, 24, 48, 72, 96, 168