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

May 27, 2009 updated by: Mast Therapeutics, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • Parexel International - Baltimore CPRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CoFactor
Drug: CoFactor
Other Names:
  • ANX-510
Experimental: 2
CoFactor
Drug: CoFactor
Other Names:
  • ANX-510
Active Comparator: 3
Leucovorin
Drug: Leucovorin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.

Secondary Outcome Measures

Outcome Measure
To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mast Therapeutics, Inc.

Investigators

  • Principal Investigator: Ronald Goldwater, MD, Parexel International - Baltimore CPRU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2009

Last Update Submitted That Met QC Criteria

May 27, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoFactor 510-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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