Overview

Pharmacokinetic Issues of Moxifloxacin Plus Rifapentine

Status:
Terminated
Trial end date:
2008-08-24
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Johns Hopkins University
Treatments:
Fluoroquinolones
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Rifampin
Rifapentine