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

NCT05258877 | Completed

• 1 other identifier: Eto-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Plasma samples OTHER

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pulmonary Tuberculosis

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• BioVersys AG: lead
• TASK Applied Science: collaborator

Study Sites (1)

TASK Applied Sciences

Cape Town, 7500, South Africa

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Glenn Dale

  BioVersys AG

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: June 10, 2022
• Primary Completion: September 28, 2023
• Study Completion: September 30, 2023
• Last Updated: November 21, 2023

Record last verified: 2022-09

Locations

ZA (1)