Phase 1
N=12
A Study to Understand the Effect of Low-Fat and High-Fat Meals on the Medicine Called PF-07284890 in Healthy Adults
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT05349864 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition — 28270; 23510 Nanogram*Hour per Milliliter (ng*hr/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-07284890 Treatment A (Drug); PF-07284890 Treatment B (Drug); PF-07284890 Treatment C (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition |
28270; 23510 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition |
29380; 24600 | — |
| PRIMARY Maximum Observed Concentration (Cmax) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition |
3460; 1672 | — |
| PRIMARY AUClast of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition |
31300; 23510 | — |
| PRIMARY AUCinf of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition |
34130; 24600 | — |
| PRIMARY Cmax of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition |
3892; 1672 | — |
| SECONDARY Time to Reach Cmax (Tmax) of PF-07284890 in Plasma |
3.00; 3.00; 4.01 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) of PF-07284890 in Plasma |
16.36; 17.73; 16.19 | — |
| SECONDARY Apparent Clearance (CL/F) of PF-07284890 in Plasma |
8.130; 6.810; 5.860 | — |
| SECONDARY Apparent Volume of Distribution for Extravascular Dosing (Vz/F) of PF-07284890 in Plasma |
186.4; 168.5; 132.9 | — |
| SECONDARY Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) |
5; 3; 2 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Pre-Specified Categorization Criteria for Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs) |
0; 0; 0; 0; 0; 0 | — |
Summary
The purpose of the study is to evaluate the effect of a low-fat and high-fat meal on the medicine called PF-07284890 following three single doses PF-07284890. The study will include male participants and female participants of non-childbearing potential who are healthy. Participants will be required to stay in the clinical research unit for 15 days and 14 nights.
Eligibility Criteria
Inclusion Criteria
- Females of non-childbearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Exclusion Criteria
- Evidence or history of clinically significant uveitis, 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), including any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
Data sourced from ClinicalTrials.gov (NCT05349864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.