Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Bioavailability Study Comparing 3 Different AZD1981 Tablets

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: NCT01311635
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : July 7, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 3, 2011
First Posted Date  ICMJE March 9, 2011
Last Update Posted Date July 7, 2011
Study Start Date  ICMJE April 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981 [ Time Frame: Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
  • To evaluate basic systemic PK parameters as follows: [ Time Frame: PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period ]
    • AUC(0-t): area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration
    • tmax: time to reach Cmax
    • t1/2λz: terminal half-life
    • CL/F: apparent plasma clearance
    • MRT: apparent mean residence time
    • Vz/F: apparent volume of distribution during terminal phase
  • To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight [ Time Frame: Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study ]
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 A Bioavailability Study Comparing 3 Different AZD1981 Tablets
Official Title  ICMJE A Phase I, Open Label, Randomised, 4-way Crossover Study to Investigate the Relative Bioavailability of Single Dose AZD1981 Via 3 Different Tablets in Healthy Men and Healthy Women of Non-childbearing Potential
Brief Summary The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: AZD1981, current small-particle tablet
    3x100 mg per oral, single dose in fasted state
  • Drug: AZD1981, new small-particle tablet
    3x100 mg per oral, single dose
  • Drug: AZD1981, new large-particle table
    3x100 mg per oral, single dose in fasted state
Study Arms  ICMJE
  • Experimental: Treatment A
    Intervention: Drug: AZD1981, current small-particle tablet
  • Experimental: Treatment B
    Intervention: Drug: AZD1981, new small-particle tablet
  • Experimental: Treatment C
    Intervention: Drug: AZD1981, new small-particle tablet
  • Experimental: Treatment D
    Intervention: Drug: AZD1981, new large-particle table
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: March 8, 2011)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
  • Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
  • Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.

Exclusion Criteria:

  • Any clinically significant disease or disorder
  • Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
  • Prolonged QTcF >450 ms or shortened QTcF<340 ms at Visit 1 or family history of long QT syndrome
  • History of, or current alcohol or drug abuse
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 Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01311635
Other Study ID Numbers  ICMJE D9830C00020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christer Hultquist / MD, AstraZeneca R&D
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wolfgang Kühn, MD Quintiles AB, Phase 1 Services
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