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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02387242
• Other study ID #: High Rif-WBA
• Status: Suspended
• Phase: Phase 1
• First received: February 24, 2015
• Last updated: April 12, 2017
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 18
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mycobacterium Infections
• Tuberculosis

Intervention

Drug:
• Rifampicin
Single oral dose of rifampicin

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in host cytokine response after study drug administration	Impact of host immune response before and after drug administration	6 hours following administration
Primary	Cumulative WBA (reported as change in Mtb log CFU per day)		24 hours
Secondary	The pharmacokinetic profile of rifampicin		24 hours