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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00663481
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : May 28, 2009
Information provided by:
Mast Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Adults Drug: CoFactor Drug: Leucovorin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : April 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Leucovorin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: CoFactor
Other Name: ANX-510
Experimental: 2
Drug: CoFactor
Other Name: ANX-510
Active Comparator: 3
Drug: Leucovorin

Primary Outcome Measures :
  1. Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.

Secondary Outcome Measures :
  1. To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00663481

United States, Maryland
Parexel International - Baltimore CPRU
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Mast Therapeutics, Inc.
Principal Investigator: Ronald Goldwater, MD Parexel International - Baltimore CPRU

Responsible Party: Jeff Stewart, MBA, ADVENTRX Pharmaceuticals, Inc. Identifier: NCT00663481     History of Changes
Other Study ID Numbers: CoFactor 510-20
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: May 28, 2009
Last Verified: May 2009

Keywords provided by Mast Therapeutics, Inc.:

Additional relevant MeSH terms:
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs