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

April 12, 2017 updated by: National University Hospital, Singapore

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

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).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
10mg/kg Rifampicin
Drug: Rifampicin
Single oral dose of rifampicin
Other Names:
  • Rifampin
EXPERIMENTAL: Group 2
20mg/kg Rifampicin
Drug: Rifampicin
Single oral dose of rifampicin
Other Names:
  • Rifampin
EXPERIMENTAL: Group 3
30mg/kg Rifampicin
Drug: Rifampicin
Single oral dose of rifampicin
Other Names:
  • Rifampin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative WBA (reported as change in Mtb log CFU per day)
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The pharmacokinetic profile of rifampicin
Time Frame: 24 hours
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in host cytokine response after study drug administration
Time Frame: 6 hours following administration
Impact of host immune response before and after drug administration
6 hours following administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (ESTIMATE)

March 12, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • High Rif-WBA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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