Clinical trial: A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects. (NCT00663481)

Eligibility 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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Entailment