NCT01554800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 coronary-artery-disease

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 14, 2019

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

March 13, 2012

Last Update Submit

March 12, 2019

Conditions

Coronary Artery DiseaseAtherosclerosis

Keywords

Lecithin Cholesterol Acyl TransferaseLCATrhLCATEnzyme replacement therapyHigh-Density Lipoprotein (HDL)CholesterolCholesterol esterLCAT Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

ACP-501

EXPERIMENTAL
Drug: ACP-501

Interventions

ACP-501DRUG

A single dose infusion

ACP-501

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular and Pulmonary Branch (CPB) of NIH

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Shamburek RD, Bakker-Arkema R, Shamburek AM, Freeman LA, Amar MJ, Auerbach B, Krause BR, Homan R, Adelman SJ, Collins HL, Sampson M, Wolska A, Remaley AT. Safety and Tolerability of ACP-501, a Recombinant Human Lecithin:Cholesterol Acyltransferase, in a Phase 1 Single-Dose Escalation Study. Circ Res. 2016 Jan 8;118(1):73-82. doi: 10.1161/CIRCRESAHA.115.306223. Epub 2015 Dec 1.

    PMID: 26628614DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosisLecithin Cholesterol Acyltransferase Deficiency

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHypoalphalipoproteinemiasHypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 15, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 14, 2019

Record last verified: 2013-01

Locations

US(1)