A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.
Information source: Adventrx Pharmaceuticals
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Adults
Intervention: CoFactor (Drug); Leucovorin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Adventrx Pharmaceuticals Official(s) and/or principal investigator(s):
Ronald Goldwater, MD, Principal Investigator, Affiliation: Parexel International - Baltimore CPRU
Overall contact:
Brooke Evans, RN, Phone: 410-350-7938
Summary
The purpose of this study is to determine the safety and tolerability of CoFactor in healthy
subjects.
Clinical Details
Official title: A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects.
Study design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.
Secondary outcome: To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Brooke Evans, RN, Phone: 410-350-7938
Parexel International - Baltimore CPRU, Baltimore, Maryland 21225, United States; Recruiting
Additional Information
Starting date: April 2008
Last updated: April 18, 2008
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