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The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668 in healthy male subjects.
This is an exploratory study to assess the absolute bioavailability of a single oral dose of AZD9668 with respect to an intra-venous microdose of [14C]AZD9668 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD9668 | Experimental | Tablets and intravenous (IV) dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9668 | Drug | Tablets of AZD9668 and IV dose of [C14]AZD9668 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The absolute bioavailability and evaluation of pharmacokinetic parameters (AUC, AUC (0-t), Cmax, t½, tmax, and MRT of of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668 | Multiple Pharmacokinetic blood samples for up to 96 hours following drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD9668: Adverse events, clinical chemistry, haematology, urinalysis, vital signs, electrocardiogram, physical examination | measured within 21 days of drug administration and up to 7 days following drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Marks-Konczalik | AstraZeneca | Study Director |
| Sharan Sidhu, MB ChB, BAO, | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ruddington | Nottingham | United Kingdom | |||
| Research Site |
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| ID | Term |
|---|---|
| C568080 | N-((5-(methanesulfonyl)pyridin-2-yl)methyl)-6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-2-oxo-1-(3-(trifluoromethyl)phenyl)-1,2-dihydropyridine-3-carboxamide |
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| London |
| United Kingdom |