Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects

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 55 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.

5. 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.

6. Subject agrees to abstain from caffeine and theobromine containing products and the
consumption of Seville oranges, grapefruit (including grapefruit juice), broccoli,
brussel sprouts, charcoal grilled meat, and energy drinks from 48 hours before study
drug administration and throughout the clinical phase of the study.

Exclusion Criteria:

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

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

3. 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 drinks/week) for women. 1 unit of alcohol 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),
or a glass of wine (100 mL).

4. Blood or plasma donation within past 2 months.

5. History of hypersensitivity to glycopeptide antibiotics (that have a similar chemical
structure to oritavancin) or to any of the excipients of oritavancin.

6. History of hypersensitivity to warfarin or other 4-hydroxycoumarins, or to any of the
excipients of warfarin.

7. 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.

8. Treatment with any prescription or OTC (over the counter) drugs 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 above mentioned
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.

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

10. 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)

11. Known protein C or protein S deficiency.

12. Inflammatory Bowel Disease or conditions which may decrease the absorption of
warfarin.

13. History of bleeding tendencies (e.g history of menorrhagia, gastrointestinal
bleeding).

14. History of heparin-induced thrombocytopenia.

15. Surgery within the last 30 days.