Status:
TERMINATED
Pharmacokinetic Issues of Moxifloxacin Plus Rifapentine
Lead Sponsor:
Johns Hopkins University
Conditions:
Mycobacterium Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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. Resea...
Detailed Description
New drugs are urgently needed to shorten the duration of tuberculosis (TB) treatment and to facilitate the delivery of directly observed therapy. Preliminary data indicates that a TB treatment regimen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00460759
Start Date
June 1 2007
End Date
August 24 2008
Last Update
December 7 2017
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287