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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

Tracking Information
First Submitted Date  ICMJE November 6, 2015
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date April 13, 2017
Study Start Date  ICMJE November 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02602509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
  • Plasma concentrations of study drugs to determine the Area Under the Curve (AUC) [ Time Frame: 8 hours ]
  • Plasma concentrations of study drugs to determine the Maximum Plasma Concentration (Cmax) [ Time Frame: 8 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers
Official Title  ICMJE Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tuberculosis
Intervention  ICMJE
  • Drug: Celecoxib
    Other Name: Celebrex
  • Drug: Rifampicin
    Other Name: Rifampin
  • Drug: Pyrazinamide
Study Arms  ICMJE
  • Experimental: Celecoxib plus rifampicin group
    Visit 1: Celecoxib 400mg Visit 2: Rifampicin 10mg/kg Visit 3: Celecoxib 400mg PLUS rifampicin 10mg/kg
    Interventions:
    • Drug: Celecoxib
    • Drug: Rifampicin
  • Experimental: Celecoxib plus pyrazinamide group
    Visit 1: Celecoxib 400mg Visit 2: Pyrazinamide 25mg/kg Visit 3: Celecoxib 400mg PLUS pyrazinamide 25mg/kg
    Interventions:
    • Drug: Celecoxib
    • Drug: Pyrazinamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2015)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02602509
Other Study ID Numbers  ICMJE Celecoxib_WBA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicholas Paton National University Hospital, Singapore
PRS Account National University Hospital, Singapore
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP