Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-005201-39 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the impact of CYP3A4 inhibitor, itraconazole, on plasma concentration of PF-06649751 in healthy subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF06649751, Itraconazole | Drug | PF-06649751 0.25 mg on Days 1,2,3 PF-06649751 0.5 mg on Days 4,5,6 PF-06649751 1 mg on Days 7 to Day 25 Itracoanzole 200 mg on Days 12 to Day 25 |
|
| Measure | Description | Time Frame |
|---|---|---|
| PF-06649751 and PF-06752844 steady state Cmax | Maximum Observed Plasma Concentration | Day 11 and Day 25 |
| PF-06649751 and PF-06752844 steady state AUC24 | Area Under the Curve From Time Zero to the end of the dosing period | Days 11 and Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior"). |
Not provided
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
Exclusion Criteria:
Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 0 |
| Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior"). | Day 7 |
| Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior"). | Day 14 |
| Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior"). | Day 21 |
| Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior"). | Day 26 |
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant 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 Y days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug X was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Day 1 to Day 26 |
| D010879 |
| Piperazines |