Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Celecoxib; Pyrazinamide; Rifampin

Criteria

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