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

Phase 1

Completed

• Conditions: Healthy Adults
• Interventions: Drug: CoFactor; Drug: Leucovorin

• Registration Number: NCT00663481
• Lead Sponsor: Mast Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-22
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-27
• Last Update Posted: 2009-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	CoFactor	CoFactor
2	CoFactor	CoFactor
3	Leucovorin	Leucovorin

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.

Secondary Outcome Measures

Name	Time	Method
To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration

Trial Locations

Locations (1)

Parexel International - Baltimore CPRU; 🇺🇸 Baltimore, Maryland, United States