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RecruitingPhase 1ACTRN12617001643369

Inhaled rifampicin study in healthy individuals

Inhaled rifampicin safety and dose finding proof of concept study in healthy volunteers

Sponsor

University of Otago

Enrollment

50 participants

Start Date

Jan 11, 2025

Study Type

Interventional

Conditions

Tuberculosis

Summary

Tuberculosis (TB), caused by Mycobacterium tuberculosis, is a disease mainly of the lungs. Rifampicin, a first-line anti-TB medicine, is given orally for 6 months, and only a small fraction of the dose goes to the lung. Direct delivery of rifampicin to the lungs by inhalation can achieve high drug levels in the lung and in blood to kill M. tuberculosis more effectively throughout the body.This is a proof of concept study in healthy human participants to confirm safety and determine the optimal dose for inhalation. This will enable design of clinical studies combining inhaled and oral rifampicin in TB patients. Adjunct inhaled rifampicin combined with standard oral dose rifampicin has potential to change the way TB is managed worldwide by offering the prospect of a shortened treatment course from 6 months to 3-4 months.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

Tuberculosis (TB) is mainly a lung disease, and the main antibiotic used to treat it — rifampicin — is taken as a pill. Only a small amount of this pill actually reaches the lungs. This study tests whether inhaling rifampicin directly into the lungs is safe and what the best inhaled dose would be. This is a safety study in healthy volunteers, with no active TB treatment being tested here. You may be eligible if: - You are aged 18 to 55 - You are generally healthy with no ongoing medical conditions - You have normal lung function (FEV1 and FVC) - You have normal liver function tests - You are able to use inhaled medication You may NOT be eligible if: - You are on any prescription medication or have used any in the past month - You are pregnant or breastfeeding - You have a history of asthma or any lung condition - You have had previous known exposure to tuberculosis - You have abnormal lung function or liver function tests Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Rifampicin solution for nebulisation at sequential doses starting from 25 mg and higher will be administered to groups 1, 2, 3, 4 and 5 respectively through inhalation route once daily for seven days.

Rifampicin solution for nebulisation at sequential doses starting from 25 mg and higher will be administered to groups 1, 2, 3, 4 and 5 respectively through inhalation route once daily for seven days. The higher doses will include a maximum of 50, 100, 200 and 300 mg of inhaled rifampicin for groups 2, 3, 4 and 5, respectively. Group 6 will receive oral (standard dose, 600 mg) plus inhaled rifampicin (dose to be determined from pharmacokinetic analysis of data from groups 1-5) once daily for seven days. Drug administration will be witnessed and documented by the site investigator at each dosing.

Locations(1)

Otago, New Zealand

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