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Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

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: NCT01336218
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 14, 2011
First Posted Date  ICMJE April 15, 2011
Last Update Posted Date July 22, 2011
Study Start Date  ICMJE April 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured [ Time Frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
  • To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured [ Time Frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose ]
  • To examine the safety and tolerability of fostamatinib in combination with rifampicin. [ Time Frame: From screening, Day 1 - Day 25, up to follow up visit ]
    Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported.
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 Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.
Official Title  ICMJE An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin
Brief Summary The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Rheumatoid Arthritis
  • Healthy Volunteers
Intervention  ICMJE
  • Drug: fostamatinib
    oral tablets, 150mg (3 X 50mg) single dose per period
  • Drug: rifampicin
    oral tablets, 600mg (2 X 300mg) 8 doses over 8 days
Study Arms  ICMJE
  • Experimental: 1
    Fostamatinib
    Intervention: Drug: fostamatinib
  • Experimental: 2
    Rifampicin
    Interventions:
    • Drug: fostamatinib
    • Drug: rifampicin
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
Estimated Enrollment  ICMJE
 (submitted: April 14, 2011)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Males or females aged 18 to 55 years (inclusive)
  • Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
  • Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential

Exclusion Criteria:

  • History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
  • Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
  • Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
  • Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
  • Any previous treatment with fostamatinib
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01336218
Other Study ID Numbers  ICMJE D4300C00015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kelli Craven, MD, PI, Quintiles, Overland Park, volunteer recruitment
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date July 2011

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