The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed,
distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with
rifapentine. Researchers believe that understanding how these tuberculosis drugs interact
when given together may help to determine the best drug treatment plan for use in future
studies. Volunteers will take moxifloxacin daily by mouth for the first part of the study and
then moxifloxacin in combination with rifapentine during the second part of the study.
Sixteen healthy men and women will be recruited from Johns Hopkins University School of
Medicine to volunteer for this study. They will be required to stay in the inpatient unit
twice, each time for 84 hours. Study procedures will include having a tube placed in a vein
to draw several blood samples over time. Volunteers will participate in the study for a
maximum of 48 days, including screening and follow-up visits.
Minimum age: 18 Years.
Maximum age: 65 Years.
- Ability and willingness to provide written informed consent.
- Age greater than or equal to 18 years, and less than or equal to 65 years.
- Within 14 or fewer days prior to enrollment, a complete blood count, comprehensive
serum chemistry profile, and HIV antibody test will be performed, with the following
- Serum amino aspartate transferase (AST) at or within the normal limits for the
- Total bilirubin level at, below, or within the normal limits for the laboratory
- Creatinine level at, below, or within the normal limits for the laboratory
- Uric acid at, below, or within the normal limits for the laboratory
- Hemoglobin greater than 12. 0 for men, greater than 11. 0 for women
- Platelet count greater than or equal to 125,000/cu mm
- Absolute neutrophil count greater than or equal to 1250/cu mm
- Potassium level of at least 3. 5 mEq/L
- Serum albumin at or within normal limits for the laboratory
- HIV antibody test negative
- For women of childbearing potential, a negative serum beta-Human Chorionic
Gonadatropin (bHCG) pregnancy test, performed at screening and on Day 0.
- During the study and for 14 days after the last dose of study medication, women of
childbearing potential must agree to practice a double-barrier method of birth control
(e. g., condom plus spermicidal foam, condom plus diaphragm, etc) or to abstain from
heterosexual vaginal intercourse since hormonal contraceptives will be prohibited
during the study. Female subjects must plan on not getting pregnant during the study
and for 14 days after the last dose of study medication.
- Access to a telephone for the duration of the study.
- Within 14 days or fewer prior to enrollment, an electrocardiogram with corrected QT
interval (QTc) less than or equal to 0. 44 seconds.
- Known intolerance to either of the study drugs or to fluoroquinolone antibiotics
- Use of rifamycin or fluoroquinolone antibiotics in the 30 days prior to enrollment
- Inability to take oral medications
- History of any renal, hepatic, cardiac (except benign heart murmur), or endocrine
disorder; or malignancy; or immunocompromised
- History of any acute or chronic illness that requires current medical therapy
- Prior gastrointestinal surgery involving stomach, biliary system, pancreas, or small
- Any medical condition that, in the opinion of the investigator, would interfere with
the subject's ability to participate in the protocol
- Any illicit drug use within the preceding 2 months. Subjects must agree to abstain
from alcohol, tobacco, and illicit drug use during the study
- Current use of any prescription medication(s)
- 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), or over-the-counter medication(s) with the exception of acetaminophen
- History of prolonged QT syndrome
- Participation in any other investigational drug study within 21 days prior to study
entry and during the study
- Inability to participate in pharmacokinetic visits