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

Primary Purpose

Tuberculosis

Status

Suspended

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

Rifampicin

About this trial

This is an interventional treatment trial for Tuberculosis focused on measuring Tuberculosis, Whole blood Bactericidal Activity, WBA, Rifampicin

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged 21 and above
Male or female willing to comply with the study visits and procedures
Willing and able to provide written informed consent

Exclusion Criteria:

Women who are currently pregnant or breastfeeding
Signs of active TB
On immunosuppressant, antibiotic or any medication known to have interaction with rifampicin
Previous allergy to Rifampicin
Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
Known hepatic disease or alcohol abuse
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
Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial
Current participation in other clinical intervention trial or research protocol

Sites / Locations

National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

10mg/kg Rifampicin

20mg/kg Rifampicin

30mg/kg Rifampicin

Outcomes

Primary Outcome Measures

Cumulative WBA (reported as change in Mtb log CFU per day)

Secondary Outcome Measures

The pharmacokinetic profile of rifampicin

Full Information

NCT ID

NCT02387242

First Posted

February 24, 2015

Last Updated

April 12, 2017

Sponsor

National University Hospital, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT02387242

Brief Title

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

Official Title

Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single 'High' Doses of Rifampicin in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Suspended

Why Stopped

New relevant data published

Study Start Date

February 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National University Hospital, Singapore

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

Keywords

Tuberculosis, Whole blood Bactericidal Activity, WBA, Rifampicin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

10mg/kg Rifampicin

Arm Title

Group 2

Arm Type

Experimental

Arm Description

20mg/kg Rifampicin

Arm Title

Group 3

Arm Type

Experimental

Arm Description

30mg/kg Rifampicin

Intervention Type

Drug

Intervention Name(s)

Rifampicin

Other Intervention Name(s)

Rifampin

Intervention Description

Single oral dose of rifampicin

Primary Outcome Measure Information:

Title

Cumulative WBA (reported as change in Mtb log CFU per day)

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

The pharmacokinetic profile of rifampicin

Time Frame

24 hours

Other Pre-specified Outcome Measures:

Title

Change in host cytokine response after study drug administration

Description

Impact of host immune response before and after drug administration

Time Frame

6 hours following administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 21 and above Male or female willing to comply with the study visits and procedures Willing and able to provide written informed consent Exclusion Criteria: Women who are currently pregnant or breastfeeding Signs of active TB On immunosuppressant, antibiotic or any medication known to have interaction with rifampicin Previous allergy to Rifampicin Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations Known hepatic disease or alcohol abuse 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 Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial Current participation in other clinical intervention trial or research protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas Paton

Organizational Affiliation

National University Hospital, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University Hospital

City

Singapore

Country

Singapore

12. IPD Sharing Statement

Learn more about this trial

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

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