To determine the pharmacokinetics of ethionamide (Eto) and ethionamide-sulfoxide (Eto-SO) in participants with tuberculosis (TB) when Eto is dosed under programmatic conditions.
A single-centre, open-label, exploratory pharmacokinetic study. This study is designed to collect blood samples from participants established on a TB treatment regimen which includes Eto. These samples will be analysed for concentrations of Eto and its metabolite Eto-SO. The medication will not be provided by the study, participants will receive their standard of care medication from their local clinic. Participants will continue to take their total daily dose of Eto on study as prescribed by their primary caregiver, this will not change for their participation on study.
Study Type
OBSERVATIONAL
Enrollment
30
Up to 80ml of plasma may be collected from each participant over the 24 hour sampling period to be used for PK analysis.
TASK Applied Sciences
Cape Town, South Africa
To determine the Cmax of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
maximum observed plasma drug concentration (Cmax)
Time frame: 2 days
To determine the Cmax of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
maximum observed plasma drug concentration (Cmax)
Time frame: 2 days
To determine the AUC of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
area under the plasma drug concentration versus time (AUC0-24)
Time frame: 2 days
To determine the AUC of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
area under the plasma drug concentration versus time (AUC0-24)
Time frame: 2 days
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