Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers

Exclusion Criteria

• •1. Pregnant or breastfeeding
• •2. Known intolerance of or allergy to rifamycins
• •3. Allergy to benzodiazepines
• •4. Use of rifamycin antibiotics in the 30 days prior to enrollment
• •5. Inability to take oral medications
• •6. Renal, hepatic, cardiac (except benign heart murmur), or endocrine disorder; or malignancy; or immunocompromise.
• •7. History of any acute or chronic illness that requires current medical therapy.
• •8. Prior gastrointestinal surgery involving stomach, biliary system, pancreas, or small intestine.
• •9. Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in the protocol.
• •10. Any illicit drug use within the preceding 2 months. Subjects must agree to abstain from alcohol and illicit drug use during the study. Smokers must agree to abstain from cigarettes or to smoke fewer than 5 cigarettes per day.
• •11. Current use of any prescription medication(s), including oral contraceptives.
• •12. Planned use, during the study from Day 0 through the last PK blood draw, of any of the following: prescription medication(s), herbal supplement(s), vitamin(s), mineral supplement(s), over-the-counter medication(s), or grapefruit juice. Subjects must agree to abstain from grapefruit juice during the study.
• •13. Participation in any other investigational drug study within 30 days prior to study entry and during study.
• •14. Inability to participate in pharmacokinetic visits