Healthy, Postmenopausal, Surgically Sterile Women
Conditions
Brief summary
The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance
Interventions
DRUGAZD1981
100 mg iv infusion, single dose, 4 hours infusion
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety variables (adverse events and laboratory safety lab) | Adverese events registered during study and vital signs and ECG at visit 1,2 ,6 |
Countries
Sweden
Outcome results
None listed