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

NCT00663481 | Completed Phase 1

• 1 other identifier: CoFactor 510-20
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adults

Keywords

CoFactor; ANX-510

Outcome Measures

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

Study Arms (3)

1

EXPERIMENTAL

CoFactor

Drug: CoFactor

2

EXPERIMENTAL

CoFactor

Drug: CoFactor

3

ACTIVE COMPARATOR

Leucovorin

Drug: Leucovorin

Interventions

CoFactor DRUG

Also known as: ANX-510

1; 2

Leucovorin DRUG

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mast Therapeutics, Inc.: lead

Study Sites (1)

Parexel International - Baltimore CPRU

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

5,11-methenyltetrahydrohomofolate; Leucovorin

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Ronald Goldwater, MD

  Parexel International - Baltimore CPRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 28, 2009

Record last verified: 2009-05

Locations

US (1)