AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations
- Registration Number
- NCT00918398
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Men or post-menopausal or surgically sterile women, aged 18 to 55 years
- Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)
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 phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 AZD1981 AZD1981, 100 mg iv infusion 2 AZD1981 AZD1981, 514 mg oral solution 4 AZD1981 AZD1981, 500 mg oral tablet B 3 AZD1981 AZD1981, 500 mg oral tablet A
- Primary Outcome Measures
Name Time Method PK samples for AZD1981 from both blood and urine Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.
- Secondary Outcome Measures
Name Time Method Safety variables (adverse events and laboratory safety lab) Adverese events registered during study and vital signs and ECG at visit 1,2 ,6
Trial Locations
- Locations (1)
Research Site
🇸🇪Uppsala, Sweden