Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602509
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief 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.

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: Celecoxib Drug: Rifampicin Drug: Pyrazinamide Phase 1

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers
Study Start Date : November 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Celecoxib plus rifampicin group
Visit 1: Celecoxib 400mg Visit 2: Rifampicin 10mg/kg Visit 3: Celecoxib 400mg PLUS rifampicin 10mg/kg
Drug: Celecoxib
Other Name: Celebrex

Drug: Rifampicin
Other Name: Rifampin

Experimental: Celecoxib plus pyrazinamide group
Visit 1: Celecoxib 400mg Visit 2: Pyrazinamide 25mg/kg Visit 3: Celecoxib 400mg PLUS pyrazinamide 25mg/kg
Drug: Celecoxib
Other Name: Celebrex

Drug: Pyrazinamide



Primary Outcome Measures :
  1. Log change CFU.day (cumulative over 8 hours) calculated from Mycobacteria Growth Indicator Tube (MGIT) Time to Positivity [ Time Frame: 8 hours ]
    Cumulative whole blood bactericidal activity (WBA)


Secondary Outcome Measures :
  1. Plasma concentrations of study drugs to determine the Area Under the Curve (AUC) [ Time Frame: 8 hours ]
  2. Plasma concentrations of study drugs to determine the Maximum Plasma Concentration (Cmax) [ Time Frame: 8 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602509


Locations
Layout table for location information
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Layout table for investigator information
Principal Investigator: Nicholas Paton National University Hospital, Singapore

Layout table for additonal information
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02602509     History of Changes
Other Study ID Numbers: Celecoxib_WBA
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: November 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Celecoxib
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifampin
Pyrazinamide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers