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

This study has been completed.

First Received on April 18, 2008. Last Updated on May 27, 2009 History of Changes

Sponsor:	Adventrx Pharmaceuticals
Information provided by:	Adventrx Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00663481

Purpose

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

Condition	Intervention	Phase
Healthy Adults	Drug: CoFactor Drug: Leucovorin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Adventrx Pharmaceuticals:

Primary Outcome Measures:

Pharmacokinetic profile of CoFactor formulations in healthy adult subjects. [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	April 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 CoFactor	Drug: CoFactor Other Name: ANX-510
Experimental: 2 CoFactor	Drug: CoFactor Other Name: ANX-510
Active Comparator: 3 Leucovorin	Drug: Leucovorin

Eligibility

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663481

Locations

United States, Maryland
Parexel International - Baltimore CPRU
Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

Adventrx Pharmaceuticals

Investigators

Principal Investigator:

Ronald Goldwater, MD

Parexel International - Baltimore CPRU

More Information

No publications provided

Responsible Party:	Jeff Stewart, MBA, ADVENTRX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00663481 History of Changes
Other Study ID Numbers:	CoFactor 510-20
Study First Received:	April 18, 2008
Last Updated:	May 27, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Adventrx Pharmaceuticals:

CoFactor
ANX-510

Additional relevant MeSH terms:

Leucovorin
Levoleucovorin
Vitamin B Complex
Vitamins
Micronutrients

Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012