Status:
COMPLETED
Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants
Lead Sponsor:
Pfizer
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants. This is an open-labe...
Eligibility Criteria
Inclusion
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg.
Exclusion
- Evidence of congestive heart failure or history of congestive heart failure or any of the following: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident including transient ischemic attack or pulmonary embolus.
- Known hypersensitivity to itraconazole or it excipients or to other azole antifungals.
- Infection with Hepatitis B, C or HIV
- Known present or history of malignancy other than a successfully treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03821493
Start Date
February 21 2019
End Date
June 4 2019
Last Update
June 28 2019
Active Locations (1)
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1
Pfizer Clinical Research Unit
Brussels, Be-bru, Belgium, B-1070