Pharmacokinetic Issues of Moxifloxacin Plus Rifapentine

• Status: Terminated
• Trial end date: 2008-08-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Rifampin; Rifapentine

Criteria

Inclusion Criteria:

• 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 laboratory values:

• Serum amino aspartate transferase (AST) at or within the normal limits for the laboratory

• 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.

Exclusion Criteria:

• Breastfeeding

• 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 intestine

• 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