Clinical trial NCT05258877: Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.
Official title: A Single-centre, Open-label, Exploratory Study to Investigate the Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis, Pulmonary
Lead sponsor: BioVersys AG
Sponsor class: INDUSTRY
Collaborators: name: TASK Applied Science
First posted: 2022-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pulmonary Tuberculosis

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

Detailed description: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: To determine the Cmax of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
timeFrame: 2 days
measure: To determine the Cmax of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
timeFrame: 2 days
measure: To determine the AUC of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
timeFrame: 2 days
measure: To determine the AUC of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: TASK Applied Sciences
Study officials:
affiliation: BioVersys AG
name: Glenn Dale
role: STUDY_CHAIR
References: