Status:
COMPLETED
Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.
Lead Sponsor:
BioVersys AG
Collaborating Sponsors:
TASK Applied Science
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
18-65 years
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 sample...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
June 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05258877
Start Date
June 10 2022
End Date
September 30 2023
Last Update
November 21 2023
Active Locations (1)
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1
TASK Applied Sciences
Cape Town, South Africa, 7500