Back to resultsAZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations
Primary Purpose
Healthy, Postmenopausal, Surgically Sterile Women
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD1981
AZD1981
AZD1981
AZD1981
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
AZD1981, 100 mg iv infusion
AZD1981, 514 mg oral solution
AZD1981, 500 mg oral tablet A
AZD1981, 500 mg oral tablet B
Outcomes
Primary Outcome Measures
PK samples for AZD1981 from both blood and urine
Secondary Outcome Measures
Safety variables (adverse events and laboratory safety lab)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00918398
Brief Title
AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Postmenopausal, Surgically Sterile Women
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD1981, 100 mg iv infusion
Arm Title
2
Arm Type
Experimental
Arm Description
AZD1981, 514 mg oral solution
Arm Title
3
Arm Type
Experimental
Arm Description
AZD1981, 500 mg oral tablet A
Arm Title
4
Arm Type
Experimental
Arm Description
AZD1981, 500 mg oral tablet B
Intervention Type
Drug
Intervention Name(s)
AZD1981
Intervention Description
100 mg iv infusion, single dose, 4 hours infusion
Intervention Type
Drug
Intervention Name(s)
AZD1981
Intervention Description
514 mg oral solution, single dose
Intervention Type
Drug
Intervention Name(s)
AZD1981
Intervention Description
500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose
Intervention Type
Drug
Intervention Name(s)
AZD1981
Intervention Description
500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose
Primary Outcome Measure Information:
Title
PK samples for AZD1981 from both blood and urine
Time Frame
Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.
Secondary Outcome Measure Information:
Title
Safety variables (adverse events and laboratory safety lab)
Time Frame
Adverese events registered during study and vital signs and ECG at visit 1,2 ,6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Pettersson
Organizational Affiliation
AstraZeneca R&D, Lund, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elisabeth Eden
Organizational Affiliation
Quintiles AB, Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations
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