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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02602509
Other study ID # Celecoxib_WBA
Secondary ID
Status Completed
Phase Phase 1
First received November 6, 2015
Last updated April 12, 2017
Start date November 2015
Est. completion date February 2016

Study information

Verified date November 2015
Source National University Hospital, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of celecoxib in combination with established drugs used to treat tuberculosis (TB). Pharmacokinetics (PK) and whole blood bactericidal activity (WBA) will be measured in healthy volunteers following administration of the study drugs alone and in combination.


Description:

The whole blood bactericidal activity (WBA) assay is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial sterilisation. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. Celecoxib is a COX-2 inhibitor with immuno-modulatory properties important in the host defence against tuberculosis (TB). The aim of this trial is to investigate the effect on WBA of manipulation of the host response to TB using celecoxib, in combination with established TB drugs.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria:

1. Aged over 21 years and below 60 years old

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. Body weight below 50kg

3. Clinical signs of active TB in the opinion of the investigator

4. Previous hypersensitivity, intolerance or allergy to rifampicin, pyrazinamide, COX-2 inhibitors, non-steroidal anti-inflammatory drugs or sulfonamides

5. Current use of any drugs or medication known to have an interaction with rifampicin, pyrazinamide or celecoxib

6. Current use or use in the last 2 weeks of non-steroidal anti-inflammatory drugs or COX-2 inhibitors

7. Current use or use in the last 2 weeks of any drugs, over the counter or herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes

8. Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations

9. Known hepatic disease, recent hepatitis (within last 6 months) or alcohol abuse

10. Known cardiovascular disease, heart failure, stroke or current cardiovascular risk factors

11. Known peptic ulcer disease, previous gastrointestinal bleed or current risk factors for gastrointestinal events

12. Acute or previous gout, acute porphyria

13. Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial

14. Current participation in other clinical intervention trial or research protocol

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Celecoxib

Rifampicin

Pyrazinamide


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
Primary Log change CFU.day (cumulative over 8 hours) calculated from Mycobacteria Growth Indicator Tube (MGIT) Time to Positivity Cumulative whole blood bactericidal activity (WBA) 8 hours
Secondary Plasma concentrations of study drugs to determine the Area Under the Curve (AUC) 8 hours
Secondary Plasma concentrations of study drugs to determine the Maximum Plasma Concentration (Cmax) 8 hours
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