Expired Study
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Baltimore, Maryland 21225


Purpose:

The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.


Criteria:

Inclusion Criteria: - Males and Females age 18-65 inclusive at screening. - Subject has to agree to practice abstinence or medically accepted contraception and not to participate in sperm donation or in vitro fertilization. - Body Mass Index in the range of 18 to 30 kg/m2 and body weight of 45 to 95 kg. - Subject must be healthy as determined by the investigator on the basis of screening evaluations. - Subject must be nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the in-clinic stay. Exclusion Criteria: - Presence of clinically significant illness within 21 days prior to dosing, viral or bacterial infection, or documented drug allergies that may affect subject's safety during the study. - Laboratory or clinical evidence suggestive of disease. - Clinically significant or predisposing disorder that may interfere with the absorption, distribution, metabolism and/or excretion of drugs. - History of drug abuse within 1 year of dosing and/or admitted alcohol abuse or history of alcohol use that may interfere with the ability to comply. - Pregnant, lactating, or positive pregnancy test. - Clinically significant electrocardiogram abnormalities. - History of positive test for hepatitis B or C, or HIV. - Positive findings of urine narcotic screen. - History of drug allergy.


Study is Available At:


Original ID:

CoFactor 510-20


NCT ID:

NCT00663481


Secondary ID:


Study Acronym:


Brief Title:

A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.


Official Title:

A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects.


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Adventrx Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ronald Goldwater, MD
Principal Investigator
Parexel International - Baltimore CPRU

Study Dates

Start Date:April 2008
Completion Date:May 2008
Completion Type:Actual
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:May 2009
Last Changed Date:May 27, 2009
First Received Date:April 18, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:CoFactor
Arm Name:1
Other Name:ANX-510
Intervention Type:Drug
Name:Leucovorin
Arm Name:3

Study Arms

Study Arm Type:Active Comparator
Arm Name:3
Description:Leucovorin
Study Arm Type:Experimental
Arm Name:2
Description:CoFactor
Study Arm Type:Experimental
Arm Name:1
Description:CoFactor

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Adventrx Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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