Healthy AdultsPhase 1NCT00663481
A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.
A Phase 1 study testing CoFactor and Leucovorin in people with Healthy Adults, run by Mast Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- CoFactor and Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- History of positive test for hepatitis B or C, or HIV.
- Positive findings of urine narcotic screen.
- History of drug allergy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel International - Baltimore CPRU
Baltimore, Maryland, 21225
About this study
Official title: A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects.
The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.
- Conditions
- Healthy Adults
- Being tested
- CoFactor, Leucovorin
- Keywords
- CoFactor, ANX-510
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoFactorDrug
Also called ANX-510
LeucovorinDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CoFactor Receives: Drug: CoFactor |
| 2 | Experimental | CoFactor Receives: Drug: CoFactor |
| 3 | Active comparator | Leucovorin Receives: Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mast Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ronald Goldwater, MD, Principal investigator, Parexel International - Baltimore CPRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663481
- Sponsor's protocol ID
- CoFactor 510-20
- Status last verified
- May 2009
- First submitted
- 18 Apr 2008
- Last updated
- 28 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects.
- ClinicalTrials.gov ID
- NCT00663481
- Acronym / sponsor ID
- CoFactor 510-20
- Conditions
- Healthy Adults
- Keywords
- CoFactor, ANX-510
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CoFactorCoFactor |
| 2 | Experimental | Drug: CoFactorCoFactor |
| 3 | Active comparator | Drug: LeucovorinLeucovorin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoFactorAlso: ANX-510 | Drug | 1, 2 |
| Leucovorin | Drug | 3 |
Primary outcome
Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.
1 secondary outcome
To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Goldwater, MD principal investigator
Parexel International - Baltimore CPRU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CoFactor and Leucovorin in people with Healthy Adults, run by Mast Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2009.