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AZD8075 Single Ascending Dose Study

This study has been terminated.
(After reports of turbidity in urine in 4 of 8 volunteers in the 4th cohort, the study was halted temporarily.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00787072
First received: November 6, 2008
Last updated: November 30, 2010
Last verified: November 2010

November 6, 2008
November 30, 2010
October 2008
January 2009   (final data collection date for primary outcome measure)
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00787072 on ClinicalTrials.gov Archive Site
PK variables [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
AZD8075 Single Ascending Dose Study
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD8075 in Healthy Male Volunteers

The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: AZD8075
    Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.
  • Drug: Placebo
    Oral suspension
  • Experimental: 1
    Intervention: Drug: AZD8075
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of signed, written and dated informed consent prior to any study specific procedures.
  • Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
  • Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.

Exclusion Criteria:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
  • Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00787072
D3801C00001
No
Christer Hultquist, Medical Science Director, AstraZeneca R&D Lund, Sweden
AstraZeneca
Not Provided
Study Director: Eva Pettersson AstraZeneca R&D, Lund, Sweden
Principal Investigator: Wolfgang Kühn Quintiles, Uppsala, Sweden
AstraZeneca
November 2010

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