Clinical trial NCT03121664: A Study To Estimate The Effects Of Itraconazole On Pharmacokinetics Of Pf-06649751 In Healthy Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug drug interaction, CYP3A4, itraconazole
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-04-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: PF-06649751 and PF-06752844 steady state Cmax
timeFrame: Day 11 and Day 25
measure: PF-06649751 and PF-06752844 steady state AUC24
timeFrame: Days 11 and Day 25
Secondary outcomes:
measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Day 0
measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Day 7
measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Day 14
measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Day 21
measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Day 26
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
timeFrame: Day 1 to Day 26
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: