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AZD8075 Single Ascending Dose Study

Phase 1
Terminated
Conditions
Healthy Volunteers
Interventions
Drug: Placebo
Registration Number
NCT00787072
Lead Sponsor
AstraZeneca
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
Male
Target Recruitment
72
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1AZD8075-
2Placebo-
Primary Outcome Measures
NameTimeMethod
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)Frequent sampling occasions during study days
Secondary Outcome Measures
NameTimeMethod
PK variablesFrequent sampling occasions during study days

Trial Locations

Locations (1)

Research Site

πŸ‡ΈπŸ‡ͺ

Uppsala, Sweden

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