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| ID | Type | Description | Link |
|---|---|---|---|
| DDI | Other Identifier | Alias Study Number | |
| 2018-000694-70 | EudraCT Number |
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Drug drug interaction study between PF-05221304 and PF-06865571
A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effect of PF-05221304 on PF-06865571 PK | Experimental |
| |
| Effect of PF-06865571 on PF-05221304 PK | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06865571 administered Day 7-14 | Drug | PF-06865571 administered Q12hr on Days 7-14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. | Day 7, 0-12 hours and Day 14 0-12 hours |
| Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Day 7, 0-12 hours and Day 14 0-12 hours |
| Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. | Day 7, 0-12 hours and Day 14 0-12 hours |
| Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Day 7, 0-12 hours and Day 14 0-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Treatment-emergent AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category. |
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Inclusion criteria:
Exclusion Criteria
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Any condition possibly affecting drug absorption.
A positive urine drug test.
Screening supine BP 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec.
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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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| PF-06865571 administered Day 1-14 | Drug | PF-06865571 administered Q12hr on Day 7-14 |
|
| PF-05221304 administered Day 1-14 | Drug | PF-05221304 administered Q12hr on Days 1-14 |
|
| PF-05221304 administered Day 7-14 | Drug | PF-05221304 administered Q12hr Days 7-14 |
|
| Screening up to 28 days after last dose of study medication |