Healthy Adults
Conditions
Keywords
PF-07248144, Fluconazole, DDI, Drug-Drug Interaction
Brief summary
The purpose of the study is to learn how the study medicine called fluconazole changes how the body processes the other study medicine called PF-07248144. The study will also look at the safety, tolerability, and how the medicine is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with fluconazole. Fluconazole can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected up to 10 days after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with fluconazole.
Interventions
DRUGPF-07248144
PF-07248144 administered by mouth as a single dose in Period 1 and Period 2.
DRUGFluconazole
Fluconazole administered by mouth once a day for 13 days in Period 2.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female of nonchildbearing potential ≥ 18 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs. * Body mass index (BMI) of 18-32 kg/m2; and a total body weight \>50 kg (110 lb).
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). * Use prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07248144 - Period 1 | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose |
| AUCinf of PF-07248144 - Period 2 | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) of PF-07248144 - Period 1 | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose |
| Cmax of PF-07248144 - Period 2 | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of Treatment-Emergent Adverse Events (AE) by Severity | From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days). |
| Number of Participants With Clinically Significant Clinical Laboratories Abnormalities | From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days). |
| Number of Participants With Clinically Significant Change From Baseline in Blood Pressure or Heart Rate | From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days) |
| Number of Participants With Abnormalities in Physical Examination | From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days) |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings | From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days) |
Countries
Belgium
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed