NCT03121664CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- PF-06649751 and PF-06752844 steady state Cmax
Study Overview
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
Study Design
- Study Type
- Interventional
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Cohort 1
Experimental
Intervention: PF06649751, Itraconazole (Drug)
Outcomes
Primary Outcomes
PF-06649751 and PF-06752844 steady state Cmax
Time Frame: Day 11 and Day 25
Maximum Observed Plasma Concentration
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
- Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)(Day 26)
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)(Day 1 to Day 26)
Investigators
Study Sites (1)
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