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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Alphacore Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01554800
First received: March 13, 2012
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
Atherosclerosis
 Drug: ACP-501
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alphacore Pharma, LLC:

Primary Outcome Measures:
  • Summary of Participants Experience with Safety and Tolerability [ Time Frame: Day 1 to Day 28 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Hours 0, 1, 6, 12, 24, 48, 72, 96, 168 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACP-501 Drug: ACP-501
A single dose infusion

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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554800

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

No publications provided

Responsible Party: Alphacore Pharma, LLC
ClinicalTrials.gov Identifier: NCT01554800     History of Changes
Other Study ID Numbers: ACP 501-01, 12-H-0092
Study First Received: March 13, 2012
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alphacore Pharma, LLC:
Lecithin Cholesterol Acyl Transferase
LCAT
rhLCAT
Enzyme replacement therapy
 High-Density Lipoprotein (HDL)
Cholesterol
Cholesterol ester
LCAT Deficiency

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 16, 2013