A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.
This study has been completed.
Sponsor:
Mast Therapeutics, Inc.
Information provided by:
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00663481
First received: April 18, 2008
Last updated: May 27, 2009
Last verified: May 2009
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Purpose
The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Adults |
Drug: CoFactor Drug: Leucovorin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects. |
Resource links provided by NLM:
Further study details as provided by Mast Therapeutics, Inc.:
Primary Outcome Measures:
- Pharmacokinetic profile of CoFactor formulations in healthy adult subjects. [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2008 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
CoFactor
|
Drug: CoFactor
Other Name: ANX-510
|
|
Experimental: 2
CoFactor
|
Drug: CoFactor
Other Name: ANX-510
|
|
Active Comparator: 3
Leucovorin
|
Drug: Leucovorin |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663481
Locations
| United States, Maryland | |
| Parexel International - Baltimore CPRU | |
| Baltimore, Maryland, United States, 21225 | |
Sponsors and Collaborators
Mast Therapeutics, Inc.
Investigators
| Principal Investigator: | Ronald Goldwater, MD | Parexel International - Baltimore CPRU |
More Information
No publications provided
| Responsible Party: | Jeff Stewart, MBA, ADVENTRX Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00663481 History of Changes |
| Other Study ID Numbers: | CoFactor 510-20 |
| Study First Received: | April 18, 2008 |
| Last Updated: | May 27, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mast Therapeutics, Inc.:
|
CoFactor ANX-510 |
Additional relevant MeSH terms:
|
Leucovorin Levoleucovorin Vitamin B Complex Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013