Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00663481
First received: April 18, 2008
Last updated: May 27, 2009
Last verified: May 2009
History of Changes

April 18, 2008
May 27, 2009
April 2008
May 2008   (final data collection date for primary outcome measure)
Pharmacokinetic profile of CoFactor formulations in healthy adult subjects. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00663481 on ClinicalTrials.gov Archive Site
To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Adults
  • Drug: CoFactor
    Other Name: ANX-510
  • Drug: Leucovorin
  • Experimental: 1
    CoFactor
    Intervention: Drug: CoFactor
  • Experimental: 2
    CoFactor
    Intervention: Drug: CoFactor
  • Active Comparator: 3
    Leucovorin
    Intervention: Drug: Leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00663481
CoFactor 510-20
No
Jeff Stewart, MBA, ADVENTRX Pharmaceuticals, Inc.
Mast Therapeutics, Inc.
Not Provided
Principal Investigator: Ronald Goldwater, MD Parexel International - Baltimore CPRU
Mast Therapeutics, Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP