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

NCT ID: NCT02387242

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

10mg/kg Rifampicin

Group Type: EXPERIMENTAL

Rifampicin

Intervention Type: DRUG

Single oral dose of rifampicin

Group 2

20mg/kg Rifampicin

Group Type: EXPERIMENTAL

Rifampicin

Intervention Type: DRUG

Single oral dose of rifampicin

Group 3

30mg/kg Rifampicin

Group Type: EXPERIMENTAL

Rifampicin

Intervention Type: DRUG

Single oral dose of rifampicin

Interventions

Rifampicin

Single oral dose of rifampicin

Intervention Type: DRUG

Other Intervention Names

Rifampin

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Paton

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

High Rif-WBA

Identifier Type: -

Identifier Source: org_study_id