Phase 1
N=23
A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT05890105 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) — 1; 2; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-07853578 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) |
1; 2; 3; 2; 2; 1 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality |
4; 5; 5; 4; 5; 5 | — |
| PRIMARY Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Maximum Concentration Observed in Plasma (Cmax) |
7.196; 7.226; 14.87; 41.92; 17.92; 43.91 | — |
| SECONDARY Time to Achieve Cmax (Tmax) |
0.500; 1.08; 1.00; 0.517; 1.00; 2.00 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast) |
17.03; 43.52; 105.8; 111.6; 153.3; 462.4 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) |
18.29; 46.69; 111.5; 114.1; 157.0; 470.6 | — |
| SECONDARY Terminal Half-Life (t1/2) |
5.748; 12.78; 15.19; 8.692; 11.26; 13.15 | — |
Summary
The purposes of this study are:
* To see how the new medicine (PF-07853578) under study is tolerated. And if there are any important side effects. And, how people feel after taking single increasing amount of the medicine by mouth.
* To measure the amount of study medicine in your blood after the medicine is taken by mouth.
This study is seeking for participants who:
* are females of 18 to 65 years old and are not able to give birth to a child.
* are males of 18 to 65 years old.
* have body mass index of 16 to 31 kilograms per meter squared.
* have a total body weight of more than 50 kilograms (110 pounds). Participants will be randomly selected to receive either study medicine (PF-07853578) or placebo (a pill that has no medicine in it). Participants may receive up to 4 amounts of study medicine and up to 2 amounts of placebo.
Eligibility Criteria
Inclusion Criteria
- Female participants of non-childbearing potential and male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- BMI of 16 to 30.5 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 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, with the exception of moderate or strong cytochrome P450 3A (CYP3A) inducers or inhibitors which are prohibited within 14 days plus 5 half-lives 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). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
- Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants 1+ heme on urine dipstick.
- Albuminuria as defined by albumin/creatine (Cr) ratio on spot urine albumin (UA) >30 mg/g.
- Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), Bilirubin ≥1.05×ULN.
- Total cholesterol, triglycerides, or direct LDL ≥1.25×ULN.
Data sourced from ClinicalTrials.gov (NCT05890105). 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.