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

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

Official Title
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A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects.

Conditions
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Healthy Adults

Intervention / Treatment
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* Drug: CoFactor
* Drug: Leucovorin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CoFactor | Drug: CoFactor<br> <br> * Other names: ANX-510;|
| Experimental: 2<br>CoFactor | Drug: CoFactor<br> <br> * Other names: ANX-510;|
| Active Comparator: 3<br>Leucovorin | Drug: Leucovorin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of CoFactor formulations in healthy adult subjects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CoFactor, ANX-510