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

Completed

• Conditions: Tuberculosis, Pulmonary

• Registration Number: NCT05258877
• Lead Sponsor: BioVersys AG

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.

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Study Start: 2022-06-10
• Status Verified: 2022-09
• Primary Completion: 2023-09-28
• Study Completion: 2023-09-30
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the AUC of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.	2 days	area under the plasma drug concentration versus time (AUC0-24)
To determine the AUC of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.	2 days	area under the plasma drug concentration versus time (AUC0-24)
To determine the Cmax of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.	2 days	maximum observed plasma drug concentration (Cmax)
To determine the Cmax of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.	2 days	maximum observed plasma drug concentration (Cmax)

Trial Locations

Locations (1)

TASK Applied Sciences; 🇿🇦 Cape Town, South Africa