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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00663481

Enrollment

Registered

2008-04-22

Start date

2008-04-30

Completion date

2008-05-31

Last updated

2009-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Keywords

CoFactor, ANX-510

Brief summary

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

Interventions

DRUGCoFactor

DRUGLeucovorin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.	—

Secondary

Measure	Time frame
To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026