Clinical trial NCT03821493: Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants
Official title: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE 2-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE DOSE OF PF-06651600 IN HEALTHY PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: PF-06651600
Itraconazole
CYP3A4
Drug-Drug Interaction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-01-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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-label, fixed sequence two period study with healthy participants that will receive a single dose of PF-06651600 alone and co-administered with multiple doses of itraconazole at a single center.

Participants will be screened within 28 days of the first dose of the investigational products and if entry criteria are met, the participant will report to the clinic on the day before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive 30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The participant will be followed up by phone contact.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours
measure: Maximum observed plasma concentration of PF-06651600
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (AEs)
timeFrame: Baseline up to 35 days
measure: Number of adverse events leading to discontinuation
timeFrame: Baseline up to 35 days
measure: Number of participants with clinically significant change in vital signs from Baseline
timeFrame: Baseline to Day 9
measure: Number of participants with clinically significant abnormalities in clinical laboratory values
timeFrame: Baseline to Day 9
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
state: Be-bru
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: