Drug-drug Interaction (DDI) Rifabutin

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

1. Signed Written Informed Consent

a) Signed written informed consent must be obtained from the subjects in accordance
with requirements of the study center's Institutional Review Board (IRB) or
Independent Ethics Committee (IEC) before the initiation of any protocol-required
procedures

2. Target Population

- a) Healthy subjects as determined by no clinically significant deviation from
normal in medical history, physical examination findings, 12-lead ECG
measurements, and clinical laboratory test results

- b) Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive BMI = weight
(kg)/[height (m)]2

- c) Subject Reenrollment: This study permits the reenrollment of a subject that
has discontinued the study as a pretreatment failure (ie, subject has not been
randomized/has not been dosed). If reenrolled, the subject must be reconsented

3. Age and Reproductive Status

- a) Men and women, ages 18 to 50 years, inclusive

- b) Women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human
chorionic gonadotropin) within 24 hours prior to the start of study drug

- c) Women must not be breastfeeding

- d) WOCBP must agree to follow instructions for method(s) of contraception for the
duration of treatment plus 5 half-lives of Rifabutin (13 days) plus 30 days
(duration of ovulatory cycle) for a total of 43 days posttreatment completion

- e) Men who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception for the duration of treatment plus 5 half-lives of
Rifabutin (13 days) plus 90 days (duration of sperm turnover) for a total of 103
days posttreatment completion

Exclusion Criteria:

Medical History and Concurrent Diseases

- a) Any significant acute or chronic medical illness as determined by the Investigator.

- b) Current or recent (within 3 months of study drug administration) gastrointestinal
disease

- c) Any major surgery within 4 weeks of study drug administration

- d) Any gastrointestinal surgery that could impact upon the absorption of study drug

- e) Intractable diarrhea (≥6 loose stools per day for at least 7 consecutive days)
within 30 days prior to the first dose of study drug

- f) History of acute or chronic pancreatitis

- g) History of active or latent tuberculosis or any recent exposure to someone with
tuberculosis

- h) History of uveitis and/or current eye or vision problems with the exception of
corrective lenses

- i) Contact lens use during study drug administration or the need for contact lenses
during study drug administration

- j) Donation of blood to a blood bank or in a clinical study (except screening visit)
within 4 weeks of study drug administration (within 2 weeks for plasma donation only)

- k) Blood transfusion within 4 weeks of study drug administration.

- l) History of any hemolytic disorders, including drug-induced hemolysis.

- m) Inability to tolerate oral medication

- n) Inability to be venipunctured and/or tolerate venous access

- o) Recent (within 6 months of study drug administration) history of smoking or current
smokers

- p) Recent (within 6 months of study drug administration) drug or alcohol abuse as
defined in Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM
IV), Diagnostic Criteria for Drug and Alcohol Abuse

- q) Any other sound medical, psychiatric, and/or social reason as determined by the
Investigator