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
  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
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:


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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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
Mast Therapeutics, Inc.
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 Mast Therapeutics, Inc.:
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 April 15, 2014