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

Phase 1

Suspended

• Conditions: Tuberculosis
• Interventions: Drug: Rifampicin

• Registration Number: NCT02387242
• Lead Sponsor: National University Hospital, Singapore

Brief 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).

Detailed Description

WBA is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial killing. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. This study aims to compare different doses of rifampicin in the WBA model, compare activity of rifampicin on WBA by different mycobacterium tuberculosis strain types and assess the host immune response following drug administration.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Rifampicin	10mg/kg Rifampicin
Group 2	Rifampicin	20mg/kg Rifampicin
Group 3	Rifampicin	30mg/kg Rifampicin

Primary Outcome Measures

Name	Time	Method
Cumulative WBA (reported as change in Mtb log CFU per day)	24 hours

Secondary Outcome Measures

Name	Time	Method
The pharmacokinetic profile of rifampicin	24 hours

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore