Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

Condition(s) targeted: Tuberculosis

Intervention: moxifloxacin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
R. Aarnoutse, PharmD PhD, Principal Investigator, Affiliation: Radboud University (RUNMC)

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

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

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

Primary outcome:

Pharmacokinetic (24 hrs) curves will be drawn

at day 5 in period I and period II.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Rumah Sakit Hasan Sadikin (RSHS), Bandung, Indonesia

Starting date: January 2006
Ending date: May 2006
Last updated: May 20, 2008