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

Information source: Mast Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Adults

Intervention: CoFactor (Drug); Leucovorin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mast Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Ronald Goldwater, MD, Principal Investigator, Affiliation: Parexel International - Baltimore CPRU

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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Parexel International - Baltimore CPRU, Baltimore, Maryland 21225, United States
Additional Information

Starting date: April 2008
Last updated: May 27, 2009

Page last updated: August 23, 2015

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