AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

Study Overview
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Brief Summary
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The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance

Official Title
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An Open, Single-dose, Phase I, 4-period Partly Crossover Study in Healthy Men or Women to Assess Relative Bioavailability of Oral Administration of AZD1981 Via Tablets Compared With Suspension and Basic Systemic Pharmacokinetic Parameters After Intravenous Administration

Conditions
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Healthy, Postmenopausal, Surgically Sterile Women

Intervention / Treatment
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* Drug: AZD1981
* Drug: AZD1981
* Drug: AZD1981
* Drug: AZD1981


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1981, 100 mg iv infusion | Drug: AZD1981<br>* 100 mg iv infusion, single dose, 4 hours infusion<br>|
| Experimental: 2<br>AZD1981, 514 mg oral solution | Drug: AZD1981<br>* 514 mg oral solution, single dose<br>|
| Experimental: 3<br>AZD1981, 500 mg oral tablet A | Drug: AZD1981<br>* 500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose<br>|
| Experimental: 4<br>AZD1981, 500 mg oral tablet B | Drug: AZD1981<br>* 500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |