A Study To Estimate The Effects Of Itraconazole On Pharmacokinetics Of Pf-06649751 In Healthy Adult Subjects

Healthy Clinical Trial

Official title:

A Phase 1, Open-label, Fixed-sequence Study To Estimate The Effects Of Multiple-dose Administration Of Itraconazole On The Steady-state Pharmacokinetics Of Pf-06649751 In Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121664
• Other study ID #: B7601006
• Secondary ID: 2016-005201-39
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2017
• Last updated: November 2, 2017
• Start date: April 7, 2017
• Est. completion date: September 14, 2017

Study information

• Verified date: November 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of CYP3A4 inhibitor, itraconazole, on plasma concentration of PF-06649751 in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 14, 2017
• Est. primary completion date: September 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

• Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.

• Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:

• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).

Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.

• Unwilling or unable to comply with the Lifestyle Requirements described in this protocol

• Subjects who had a history of allergy or intolerance to azole antifungal drugs

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF06649751, Itraconazole
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

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PF-06649751 and PF-06752844 steady state Cmax	Maximum Observed Plasma Concentration	Day 11 and Day 25
Primary	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
Secondary	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 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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