Healthy Participants
Conditions
Keywords
PF-06651600, Itraconazole, CYP3A4, Drug-Drug Interaction
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.
Interventions
DRUGPF-06651600 10 mg tablets
On Day 1 in Period 1, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered. On Day 4 of Period 2, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered after itraconazole.
DRUGItraconazole Solution 200 mg
Itraconazole 200 mg will be administered as 20 mL (10 mg/mL) oral solution once daily on Days 1-5 in Period 2. On Day 4 of Period 2, co-administration of itraconazole 200 mg and PF-06651600 30 mg will occur. Itraconazole will be administered first followed by PF-06651600 tablets.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600 | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours | Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinity. |
| Maximum observed plasma concentration of PF-06651600 | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours | Peak concentration of PF-06651600 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (AEs) | Baseline up to 35 days |
| Number of adverse events leading to discontinuation | Baseline up to 35 days |
| Number of participants with clinically significant change in vital signs from Baseline | Baseline to Day 9 |
| Number of participants with clinically significant abnormalities in clinical laboratory values | Baseline to Day 9 |
Countries
Belgium
Outcome results
None listed