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Completed

NCT Number: NCT03121664

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. PF-06649751 and PF-06752844 steady state Cmax

    Time frame: Day 11 and Day 25

    Maximum Observed Plasma Concentration

  2. PF-06649751 and PF-06752844 steady state AUC24

    Time frame: Days 11 and Day 25

    Area Under the Curve From Time Zero to the end of the dosing period

Secondary outcomes

  1. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Day 0

    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").

  2. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Day 7

    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").

  3. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Day 14

    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").

  4. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Day 21

    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").

  5. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Day 26

    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").

  6. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Time frame: Day 1 to Day 26

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2017
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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