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Completed

NCT Number: NCT05258877

Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.

To determine the pharmacokinetics of ethionamide (Eto) and ethionamide-sulfoxide (Eto-SO) in participants with tuberculosis (TB) when Eto is dosed under programmatic conditions.

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

TASK Applied Sciences

Cape Town, 7500, South Africa

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide written, informed consent prior to all trial-related procedures.
  • Male or female, aged between 18 and 65 years, inclusive.
  • Receiving Eto as a component of a treatment regimen for tuberculosis for at least one month at the time of enrolment.
  • Ability and willingness of participant or legally authorized representative to provide informed consent.

Exclusion criteria

  • Evidence of clinically significant conditions or findings, other than TB, that might compromise safety of the participant or the interpretation of trial endpoints, per discretion of the Investigator.
  • Receiving prohibited concomitant medications (see Prior and Concomitant Medications)
  • Evidence of illicit substance use (cannabis, methamphetamines, opiates)
  • Pregnant or breastfeeding or planning to become pregnant during the study period.
  • Laboratory values: participants with the following laboratory values at screening
  • creatinine >1.5 times upper limit of normal [ULN];
  • haemoglobin <8.5 g/dL;
  • Alanine aminotransferase (ALT) ≥2.0 x ULN;

Treatment and study plan

plasma samples

Other

Up to 80ml of plasma may be collected from each participant over the 24 hour sampling period to be used for PK analysis.

Primary outcomes

  1. To determine the Cmax of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.

    Time frame: 2 days

    maximum observed plasma drug concentration (Cmax)

  2. To determine the Cmax of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.

    Time frame: 2 days

    maximum observed plasma drug concentration (Cmax)

  3. To determine the AUC of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.

    Time frame: 2 days

    area under the plasma drug concentration versus time (AUC0-24)

  4. To determine the AUC of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.

    Time frame: 2 days

    area under the plasma drug concentration versus time (AUC0-24)

Sponsors and collaborators

Lead sponsor

BioVersys AG

Industry

Collaborators

  • TASK Applied Science

Registry information

Official study title

A Single-centre, Open-label, Exploratory Study to Investigate the Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2022
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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