Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

Radboud University Medical Center

Status and phase

Completed

Phase 2

Conditions

Tuberculosis

Treatments

Drug: moxifloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT00306319

Primo study

UMCN-AKF 05.02

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.