Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Rifampicin in Healthy Volunteers

• Status: Suspended
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of standard and high doses of rifampicin. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following a single dose of rifampicin at standard dose (10mg/kg) or at high dose (20mg/kg or 30mg/kg).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Rifampin

Criteria

Inclusion Criteria:

1. Aged 21 and above

2. Male or female willing to comply with the study visits and procedures

3. Willing and able to provide written informed consent

Exclusion Criteria:

1. Women who are currently pregnant or breastfeeding

2. Signs of active TB

3. On immunosuppressant, antibiotic or any medication known to have interaction with rifampicin

4. Previous allergy to Rifampicin

5. Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations

6. Known hepatic disease or alcohol abuse

7. Current use of any other drugs, over the counter medications and herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes

8. Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial

9. Current participation in other clinical intervention trial or research protocol