Tuberculosis, PulmonaryNCT05258877
Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.
An observational study of Tuberculosis, Pulmonary, run by BioVersys AG at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Plasma samples
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- 10 Jun 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Pulmonary Tuberculosis
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
To determine the pharmacokinetics of ethionamide (Eto) and ethionamide-sulfoxide (Eto-SO) in participants with tuberculosis (TB) when Eto is dosed under programmatic conditions.
Read the 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.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Plasma samples
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma samplesOther
Up to 80ml of plasma may be collected from each participant over the 24 hour sampling period to be used for PK analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Cmax of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
maximum observed plasma drug concentration (Cmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start10 Jun 2022
- Primary completion28 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioVersys AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TASK Applied Science
- Responsible party
- Sponsor
- Investigators
- Glenn Dale, Study chair, BioVersys AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258877
- Sponsor's protocol ID
- Eto-001
- Status last verified
- Sep 2022
- First submitted
- 17 Feb 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05258877
- Acronym / sponsor ID
- Eto-001
- Conditions
- Tuberculosis, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BioVersys AGIndustry (pharma, biotech, devices)
- Collaborators
- TASK Applied Science
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Pulmonary Tuberculosis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma samplesUp to 80ml of plasma may be collected from each participant over the 24 hour sampling period to be used for PK analysis. | Other | – |
Primary outcome
To determine the Cmax of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
Time frame: 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.
Time frame: 2 days
maximum observed plasma drug concentration (Cmax)
To determine the AUC of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
Time frame: 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.
Time frame: 2 days
area under the plasma drug concentration versus time (AUC0-24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Dale study chair
BioVersys AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by BioVersys AG at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the Cmax of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions. (time frame: 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.