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Completed

NCT Number: NCT00663481

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International - Baltimore CPRU

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CoFactor

Drug

Other names: ANX-510

Leucovorin

Drug

Primary outcomes

  1. Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.

Secondary outcomes

  1. To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration

Sponsors and collaborators

Lead sponsor

Mast Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 22, 2008
Registry last updated
May 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.