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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022360-12 | EudraCT Number |
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The primary purpose of this study is to determine whether the treatment with AZD9668 will affect the metabolism and effect of Warfarin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | AZD9668 - 2 x30mg tablets |
|
| Treatment B | Experimental | Warfarin - 10 x2.5 mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9668 | Drug | 60 mg orally twice daily for 11 days |
| |
| Warfarin |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 1 | |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 2 | |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 3 | |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 4 | |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 5 | |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 6 | |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 7 | |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics for AZD9668 measured by Css,max | Range from day 9 to 23 | |
| Pharmacokinetics for AZD9668 measured by tss,max | Range from day 9 to 23 | |
| Pharmacokinetics for AZD9668 measured by Css,min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D O'Brien, MD, PhD | AstraZeneca R&D | Study Director |
| Ingemar Bylesjö, MD | Berzelius Clinical Reseach Centre | Principal Investigator |
| Wolfgang Kühn, MD | Quintiles AB, Phase 1 Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Linköping | Sweden | ||||
| 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 |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Drug |
10 x 2.5 (25) mg orally once daily on day 1 and on day 14 |
|
| Pharmacokinetic (PK) sampling will be performed day 8 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 9 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 10 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 11 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 12 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 13 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 14 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 15 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 16 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 17 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 18 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 19 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 20 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 21 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 22 |
| Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC) | Pharmacokinetic (PK) sampling will be performed day 23 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 1 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 2 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 3 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 4 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 5 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 6 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 7 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 8 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 9 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 10 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 11 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 12 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 13 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 14 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 15 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 16 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 17 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 18 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 19 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 20 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 21 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 22 |
| Pharmacodynamics measured by maximum international normalised ratio ( INRmax) | International normalised ratio (INR) sampling will be performed day 23 |
| Range from day 9 to 23 |
| Pharmacokinetics for AZD9668 measured by CLss/F | Range from day 9 to 23 |
| Severity of Adverse Events as a Measure of Safety and Tolerability | Adverse events will be collected pre-dose, during treatment and at follow up |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Adverse events will be collected pre-dose, during treatment and at follow up |
| Pharmacokinetics for (R)- and (S)- Warfarin measured tmax. | Range from day 1 to 23 |
| Pharmacokinetics for (R)- and (S)- Warfarin measured t½. | Range from day 1 to 23 |
| Pharmacokinetics for (R)- and (S)- Warfarin measured CL/F. | Range from day 1 to 23 |
| Pharmacokinetics for (R)- and (S)- Warfarin measured Vz/F. | Range from day 1 to 23 |
| Uppsala |
| Sweden |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |