A Study to Learn if the Study Medicine Called Fluconazole Changes How the Other Body Processes the Study Medicine PF-07248144

Pfizer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Adults

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07248144 - Period 1

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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 Outcomes

Number of Treatment-Emergent Adverse Events (AE) by Severity

Time frame: 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

Time frame: 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

Time frame: From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)

Number of Participants With Abnormalities in Physical Examination

Time frame: 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

Time frame: From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)

A Study to Learn if the Study Medicine Called Fluconazole Changes How the Other Body Processes the Study Medicine PF-07248144

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes