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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00663481
First Posted: April 22, 2008
Last Update Posted: May 28, 2009
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.
Information provided by:
Mast Therapeutics, Inc.
  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 1

Study Type: Interventional
Study Design: 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.

Further study details as provided by Mast Therapeutics, Inc.:

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

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

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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00663481


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

Responsible Party: Jeff Stewart, MBA, ADVENTRX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00663481     History of Changes
Other Study ID Numbers: CoFactor 510-20
First Submitted: April 18, 2008
First Posted: April 22, 2008
Last Update Posted: May 28, 2009
Last Verified: May 2009

Keywords provided by Mast Therapeutics, Inc.:
CoFactor
ANX-510

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