NCT00984802

Brief Summary

This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

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

First Submitted

Initial submission to the registry

September 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 20, 2011

Status Verified

June 1, 2011

Enrollment Period

1.1 years

First QC Date

September 23, 2009

Last Update Submit

June 17, 2011

Conditions

Stable Coronary Artery DiseasePercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Safety as measured by changes in CK-MB

    within 24 hours

Secondary Outcomes (2)

  • Cardiac biomarkers

    within 24 hours

  • ST segment changes

    within 24 hours

Study Arms (4)

Low dose

EXPERIMENTAL
Drug: CMX-2043

Mid Dose

EXPERIMENTAL
Drug: CMX-2043

High Dose

EXPERIMENTAL
Drug: CMX-2043

Placebo

PLACEBO COMPARATOR
Drug: Placebo control

Interventions

CMX-2043DRUG

Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.

High DoseLow doseMid Dose
Placebo controlDRUG

Vehicle solution for IV administration single dose.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have stable coronary artery disease undergoing elective PCI.
  • Female subjects not of child-bearing potential.
  • Absence of ST segment depression \>1.0 mm and absence of ST elevation \>1.0 mm in any lead on the baseline 12-lead ECG.
  • subjects with CK-MB and troponin-T levels lower than the upper limit of normal.
  • Subjects free of acute injuries or illnesses.

You may not qualify if:

  • Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease.
  • Subjects who had had an MI within 14 days prior to the PCI procedure.
  • Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD).
  • Subjects with history of TIA/stroke within 90 days or any intracranial bleed.
  • Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal.
  • Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements.
  • Subjects with a history of alcohol or drug abuse.
  • Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
  • Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct.
  • Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results.
  • Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Vincent Hospital

Worcester, Massachusetts, 01608, United States

Location

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Madras Medical Mission

Chennai, 600 037, India

Location

Hinduja Hospital

Mumbai, 400 016, India

Location

Poona Hospital

Pune, 411 030, India

Location

MeSH Terms

Interventions

alpha-N-(1,2-dithiolane-3-pentanoyl)glutamylalanine

Study Officials

  • Alan S. Lader, Ph.D.

    Ischemix, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 25, 2009

Study Start

February 1, 2010

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

June 20, 2011

Record last verified: 2011-06

Locations

US(2)IN(3)