Inhaled rifampicin study in healthy individuals

Phase 1

Conditions: Tuberculosis
Infection - Other infectious diseases
Respiratory - Other respiratory disorders / diseases

Registration Number: ACTRN12617001643369

Lead Sponsor: niversity of Otago

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Provision of signed and dated informed consent form.
2. In good general health as evidenced by medical history, no current prescription medication usage, normal FEV1 (forced expiratory volume in 1 second, ), FVC (forced vital capacity) values, normal baseline liver function test values.
3. Ability to take oral and inhaled medication

Exclusion Criteria

1. Current use of prescription medications or use in the past one month
2. Pregnancy or lactation.
3. History of asthma, or past respiratory condition and previous known exposure to TB.
4. Abnormalities on pulmonary function tests on screening and abnormalities in baseline liver function tests with ALT, ALP, BILI values > 3x ULN.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability assessment by liver function test, pulmonary function test and electrocardiogram (ECG)[ The primary time point will be of 14 days. Blood samples for liver function test will be collected at baseline, and twice a week during and after drug administration. And pulmonary function tests will also be performed at baseline and twice a week during and after drug administration. ECG test will be performed at baseline and on days 1, 3, 7, 9 and 14 of treatment.]

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters Cmax, Tmax and AUC will be assessed. [ The secondary time point is of seven days. The blood samples will be collected for pharmacokinetic assessment on the seventh day at baseline, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours.];Participant reported tolerability measured using participant's responses to questionnaire designed specifically for this study.[ ];Participant reported tolerability measured using participant's responses to questionnaire designed specifically for this study.[ 14 days after the first dose]