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

Sponsor

MedImmune LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01554800

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arm

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Atherosclerosis	Drug: ACP-501	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACP-501	Drug: ACP-501 A single dose infusion

Arm

Intervention/Treatment

Experimental: ACP-501

Drug: ACP-501

A single dose infusion

Outcome Measures

Primary Outcome Measures

Summary of Participants Experience with Safety and Tolerability [Day 1 to Day 28]
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).

Secondary Outcome Measures

Pharmacokinetic profile [Hours 0, 1, 6, 12, 24, 48, 72, 96, 168]
Change in High-Density Lipoprotein-Cholesterol (HDL-C) value following a single dose [Hours 0, 1, 6, 12, 24, 48, 72, 96, 168]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.