Clinical trial: Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers (NCT02357524)

Eligibility criteria:
Inclusion Criteria:

          1. Subject is able to provide written informed consent before initiation of any
             study-related procedures.

          2. Subject is a healthy male or female adult between 18 and 65 years of age, inclusive.

          3. Subject has a body mass index (BMI) < 45 kg/m2.

          4. Subject is in good health based on medical history and physical examination findings
             and has no clinically meaningful safety laboratory abnormalities (CBC, blood
             chemistry, and urinalysis) or 12-lead ECG results, as assessed by the Principal
             Investigator (PI).

          5. Vital signs (BP, pulse and temperature) measured at screening/baseline must be within
             the following ranges: SBP ≥90 to ≤150 mm Hg, DBP ≥45 to ≤90 mm Hg; Heart Rate ≥ 45 to
             ≤90 bpm (taken after resting in a supine position for at least 5 minutes).

          6. Female subject is surgically sterile, postmenopausal, or, if of childbearing
             potential, agrees to use at least 2 acceptable methods of birth control (e.g.
             prescription oral contraceptives, contraceptive injections, contraceptive patch,
             intrauterine device, barrier methods, abstinence) or male partner sterilization alone
             for the duration of the study until 60 days after study drug administration.

        Exclusion Criteria:

          1. Has any condition, including findings in the medical history or in prestudy
             assessments that constitutes a risk or a contraindication for the participation in the
             study or completing the study.

          2. Any coagulation test results that are outside of the normal range at Screening.

          3. Any of the following coagulation tests results that are outside of the normal range at
             Baseline (Pre-Dose): Prothrombin Time/International Normalized Ratio (PT/INR),
             Activated clotting time (ACT), Activated Partial Thromboplastin Time (APTT).

          4. Positive breath test for alcohol and/or positive urine test for drugs of abuse at
             Screening.

          5. Has a history or presence of alcohol/drug abuse within 2 years. Alcohol abuse is
             defined as regularly consuming >3 units/day (21 units per week for men), >2 units/day
             (14 units/week) for women. A unit is defined as a can of 4% beer (330 mL),
             approximately 190 mL of 6-7% beer (malt liquor), a glass of 40% spirits (30 mL), a
             glass of wine (100 mL).

          6. Blood or plasma donation within past 2 months.

          7. History of hypersensitivity to drugs with a similar chemical structure (i.e.
             glycopeptide antibiotics) to the investigational product or any of its excipients.

          8. Participation in other clinical research studies involving the evaluation of other
             investigational drugs or devices within 90 days prior to enrollment and/or unwilling
             to allow at least two months before participation in another drug trial following the
             current trial.

          9. Treatment with any prescription or OTC drugs, within 2 weeks or five half-lives,
             whichever is longer, or herbal nutritional supplements within 2 weeks of screening,
             with the exception of acetaminophen/paracetamol for minor headache. Subjects will not
             be allowed to receive medications for the duration of the study (except the
             abovementioned acetaminophen/paracetamol). Birth control or other hormone replacement
             is also permitted as long as it has been taken at a stable dose for at least three
             months before the Screening Visit and remains stable for the duration of the study.

         10. Females who are pregnant or nursing or who have a positive pregnancy test result at
             screening.

         11. Males who are unwilling to practice abstinence or use an acceptable method of birth
             control during the entire study period (i.e. condom with spermicide, where locally
             available).
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 woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years.

Patient description (patient's own words): I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL.

Does the patient match the trial criteria? 0