Exploratory Study to Assess the Pharmacokinetics of AZD5985
- Registration Number
- NCT00799331
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
- Provision of signed, written and dated informed consent prior to any study specific procedures.
- Healthy male subjects aged 18 to 45 years (inclusive).
- 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
- History or presence of any clinically significant disease or disorder in the opinion of the investigator.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
- 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
Group Intervention Description A AZD5985 AZD5985 B placebo placebo
- Primary Outcome Measures
Name Time Method It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985. Frequent sampling occasions during study days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇩🇪Berlin, Germany