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Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017

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: NCT00791752
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : June 16, 2009
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 14, 2008
Last Update Posted Date June 16, 2009
Study Start Date  ICMJE November 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratoryvariables [ Time Frame: The variables will be measure predose and the repeatedly during the following 47 hours after dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F) [ Time Frame: Blood samples for determination of AZD4017 concenration will be taken predose and repeatedly during the 47 hours post dose ]
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 Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017
Official Title  ICMJE A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase 1Study in Healthy Volunteers to Assess the Safety, Tolerability andPharmacokinetics of AZD4017 After Single Ascending Oral Doses
Brief Summary The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to healthy volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: AZD4017
    ascending single doses (start dose 2 mg), oral suspension
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    AZD4017 in ascending doses (start dose 2mg)
    Intervention: Drug: AZD4017
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
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: November 13, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of signed written and dated informed consent
  • BMI between 19 and 30 kg/m2
  • Subjects must be willing to use barrier methods of contraception

Exclusion Criteria:

  • History of any clinical significant disease
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 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 NCT00791752
Other Study ID Numbers  ICMJE D2060C00001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan Eriksson MD PhD / Medical Science Director, AstraZeneca R&D Mölndal, Sweden
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marianne Hartford, MD PhD Sahlgrenska University Sweden
PRS Account AstraZeneca
Verification Date June 2009

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