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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05258877
Other study ID # Eto-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 10, 2022
Est. completion date September 30, 2023

Study information

Verified date September 2022
Source BioVersys AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 30, 2023
Est. primary completion date September 28, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
South Africa TASK Applied Sciences Cape Town

Sponsors (2)

Lead Sponsor Collaborator
BioVersys AG TASK Applied Science

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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