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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01554800
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : March 14, 2019
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
MedImmune LLC

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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 : March 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Summary of Participants Experience with Safety and Tolerability [ Time Frame: 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 :
  1. Pharmacokinetic profile [ Time Frame: Hours 0, 1, 6, 12, 24, 48, 72, 96, 168 ]
  2. Change in High-Density Lipoprotein-Cholesterol (HDL-C) value following a single dose [ Time Frame: Hours 0, 1, 6, 12, 24, 48, 72, 96, 168 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01554800

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United States, Maryland
Cardiovascular and Pulmonary Branch (CPB) of NIH
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
MedImmune LLC
National Heart, Lung, and Blood Institute (NHLBI)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MedImmune LLC Identifier: NCT01554800     History of Changes
Other Study ID Numbers: ACP 501-01
12-H-0092 ( Other Identifier: NIH )
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: January 2013
Keywords provided by MedImmune LLC:
Lecithin Cholesterol Acyl Transferase
Enzyme replacement therapy
High-Density Lipoprotein (HDL)
Cholesterol ester
LCAT Deficiency
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases