Official Title: “Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia”

Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: May 2006

Tuberculosis is an infectious disease that still causes many victims in the developing world, especially in Indonesia. Rifampicin, isoniazid and ethambutol are the cornerstone of the current treatment. The disadvantage of the current treatment is the long, six-months, duration of the treatment. This long duration contributes to suboptimal adherence to the TB drugs.Thus, there is a very urgent need to evaluate drugs that may help shortening TB treatment. The fluoroquinolone moxifloxacin has shown early bactericidal activity (EBA) in patients with pulmonary TB, and has shown rapid and reliable sterilization. Rifampicin is a strong inducer of the CYP enzymes, but it also induces phase II metabolism. As moxifloxacin is metabolized by phase II metabolism, rifampicin could cause a decrease in the plasma concentrations of moxifloxacin. Therefore, a pharmacokinetic interaction study is warranted.

Intervention(s) in this Clinical Trial

• Drug: moxifloxacin

Primary Measures

• Pharmacokinetic (24 hrs) curves will be drawn
• at day 5 in period I and period II.

Inclusion Criteria:

• Indonesian AFB negative tuberculosis patients who are in the last two months of the continuation phase of their six-month-antituberculosis treatment.
• Subject is 18-55 years of age at the day of the first dosing of study medication.
• Subject has a normal ECG
• Subjects bodyweight is >35kg
• Use of rifampicin and isoniazid

Exclusion Criteria:

• Pregnant or lactating
• History or condition that might interfere with drug absorption, distribution, metabolism or excretion, including ileus, gastric paresis, liver and renal dysfunction, diabetes mellitus.
• Presence of contraindications for moxifloxacin or use of drugs that are known to interact with moxifloxacin.
• Subject is not able and/or not willing to sign the informed consent form.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Radboud University

Overall Clinical Trial Officials and Contacts

R. Aarnoutse, PharmD PhD Principal Investigator Radboud University (RUNMC)  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00306319

Study ID Number: UMCN-AKF 05.02

ClinicalTrials.gov Identifier: NCT00306319

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)