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

Mast Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: Leucovorin; Drug: CoFactor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663481

CoFactor 510-20

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

1

Experimental group

Description:

CoFactor

Treatment:

Drug: CoFactor

2

Experimental group

Description:

CoFactor

Treatment:

Drug: CoFactor

3

Active Comparator group

Description:

Leucovorin

Treatment:

Drug: Leucovorin