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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004238-50 | EudraCT Number |
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This is a drug interaction study to evaluate the PF-06751979 at steady state on the pharmacokinetics of oral midazolam single doses in fixed sequences including single dose midazolam alone in period 1 followed by multiple doses of 100 mg PF-06751979 once a day for 11 days with single dose midazolam co-administered on Day 10 in period 2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral midazolam alone | Experimental | single dose of oral midazolam administered alone in period 1 |
|
| oral midazolam administered with multiple doses of PF-06751979 | Experimental | single dose of midazolam on day 10 with multiple doses of PF-06751979 once a day on Days 1-11 in period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam | Drug | a single oral dose of 2 mg midazolam |
|
| Measure | Description | Time Frame |
|---|---|---|
| midazolam Area Under the Curve from time 0 to last quantifiable concentration (AUClast) in Period 1 | the plasma midazolam AUC from 0 to tlast (time of last quantifiable concentration) when a single oral midazolam dose given alone | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hrs post-dose |
| midazolam Cmax on Day 1 in Period 1 | the midazolam Cmax when single oral midazolam dose given alone | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hrs post-dose |
| midazolam Area Under the Curve from time 0 to infinite (AUCinf) in Period 1 | the plasma midazolam AUC from 0 to infinity when a single oral midazolam dose given alone | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hrs post-dose |
| midazolam AUClast in Period 2 | the plasma midazolam AUC from 0 to tlast (time of the last quantifiable concentration) when a single oral midazolam given in presence of steady state PF-06751979 | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hrs post-dose |
| midazolam Cmax in Period 2 | the midazolam Cmax when a single oral midazolam given in presence of steady state PF-06751979 | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hrs post-dose |
| midazolam AUCinf in Period 2 | the plasma midazolam AUC from 0 to infinity when a single oral midazolam given in presence of steady state PF-06751979 | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hrs post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| C000717873 | PF-06751979 |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| PF-06751979 | Drug | multiple oral doses of PF-06751979 100 mg a day |
|
| D006571 | Heterocyclic Compounds |