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

A Single-centre, Open-label, Exploratory Study to Investigate the 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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis, Pulmonary
• Intervention / Treatment: Other: Plasma samples

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa, 7500
    • TASK Applied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Pulmonary Tuberculosis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the Cmax of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.	maximum observed plasma drug concentration (Cmax)	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)	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)	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)	2 days

Collaborators and Investigators

• Sponsor: BioVersys AG
• Collaborators: TASK Applied Science
• Investigators: Study Chair: Glenn Dale, BioVersys AG

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: Eto-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No