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CompletedNCT00663481Updated May 28, 2009

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

A Phase 1 interventional study of CoFactor and Leucovorin in Healthy Adults, sponsored by Mast Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-05-28.

Sponsored by Mast Therapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Adults

Keywords

  • CoFactor
  • ANX-510
03

In context

Lead sponsor

Mast Therapeutics, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    1

    CoFactor

    Drug: CoFactor

  • Experimental
    2

    CoFactor

    Drug: CoFactor

  • Active comparator
    3

    Leucovorin

    Drug: Leucovorin

Interventions

  • DrugCoFactor

    Also known as: ANX-510

  • DrugLeucovorin
06

What researchers measure

Primary outcomes

  1. Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.

Secondary outcomes

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

07

Study locations

1 site
  • Parexel International - Baltimore CPRU
    Baltimore, Maryland 21225, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00663481
Lead sponsor
Mast Therapeutics, Inc.
First posted
Apr 22, 2008
Start date
Apr 2008
Primary completion
May 2008
Completion
May 2008
Last update
May 28, 2009

Study contacts

Ronald Goldwater, MD
principal investigator · Parexel International - Baltimore CPRU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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