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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: CoFactor
• Drug: Leucovorin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • CoFactor
• Experimental: 2
  • CoFactor
• Active Comparator: 3
  • Leucovorin

Primary Measures

• Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.
  • Safety Issue?: No

Secondary Measures

• To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration
  • Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Adventrx Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Ronald Goldwater, MD Principal Investigator Parexel International - Baltimore CPRU  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663481

Study ID Number: CoFactor 510-20

ClinicalTrials.gov Identifier: NCT00663481

Health Authority: United States: Food and Drug Administration