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

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663481
• Other study ID #: CoFactor 510-20
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2008
• Last updated: May 27, 2009
• Start date: April 2008
• Est. completion date: May 2008

Study information

• Verified date: May 2009
• Source: Mast Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• CoFactor

• Leucovorin

Locations

Country	Name	City	State
United States	Parexel International - Baltimore CPRU	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Mast Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.			No
Secondary	To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration			No