Phase 1
N=23
A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT06003777 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 5; 8; 6; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-06954522 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
5; 8; 6; 8; 6; 3 | — |
| PRIMARY Cohort 2: Number of Participants With TEAEs |
3; 0; 1; 2; 2; 0 | — |
| PRIMARY Cohort 3: Number of Participants With TEAEs |
3; 2; 4; 4; 3 | — |
| PRIMARY Cohort 1: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
0; 0; 3; 2; 1; 3 | — |
| PRIMARY Cohort 2: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
3; 1; 2; 3; 2; 1 | — |
| PRIMARY Cohort 3: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
0; 0; 0; 0; 0 | — |
| PRIMARY Cohort 1: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
0; 0; 0; 2; 0; 3 | — |
| PRIMARY Cohort 2: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
3; 0; 0; 2; 1; 0 | — |
| PRIMARY Cohort 3: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
1; 0; 1; 1; 0 | — |
| PRIMARY Cohort 1: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
2; 3; 6; 3; 3; 5 | — |
| PRIMARY Cohort 2: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
5; 1; 2; 2; 5; 1 | — |
| PRIMARY Cohort 3: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
0; 0; 2; 1; 1 | — |
| PRIMARY Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data |
0; 0; 0; 1; 0; 1 | — |
| PRIMARY Cohort 3: Number of Participants According to Categorization of Vital Signs Abnormalities Data |
0; 0; 1; 0; 1; 0 | — |
| PRIMARY Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cohort 1: Area Under the Plasma Concentration-Time Profile From Time Zero (0) to Time of Last Quantifiable Concentration (AUClast) of PF-06954522 |
1394; 4252; 7503; 5631 | — |
| SECONDARY Cohort 2: AUClast of PF-06954522 |
827.2; 12630 | — |
| SECONDARY Cohort 1: Maximum Observed Concentration (Cmax) of PF-06954522 |
112.9; 377.7; 837.6; 522.9 | — |
| SECONDARY Cohort 2: Cmax of PF-06954522 |
86.82; 1088 | — |
| SECONDARY Cohort 1: Time to Maximum Observed Concentration (Tmax) of PF-06954522 |
1.02; 3.00; 2.02; 1.09 | — |
| SECONDARY Cohort 2: Tmax of PF-06954522 |
2.04; 1.00 | — |
| SECONDARY Cohort 1: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of PF-06954522 |
1415; 4283; 7576; 5667 | — |
| SECONDARY Cohort 2: AUCinf of PF-06954522 |
846.6; 12700 | — |
| SECONDARY Cohort 1: Terminal Half-Life (t1/2) of PF-06954522 |
6.313; 8.444; 7.264; 5.958 | — |
| SECONDARY Cohort 2: t1/2 of PF-06954522 |
5.918; 7.766 | — |
Summary
The purposes of this study are:
* To see how the new medicine (PF-06954522) under study behave. And if there are any important side effects. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. The study will see 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 chosen by chance, like drawing names out of a hat to receive either:
* study medicine (PF-06954522)
* 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. The time frame of the study is approximately up to 36 days for each group and participants will stay at CRU for 20 days.
Eligibility Criteria
Inclusion Criteria
- Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, 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.
- Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of ULN;
- HbA1c ≥6.5%;
- Hematuria as defined by ≥1+ heme on urine dipstick;
- Albuminuria as defined by urine albumin/creatinine ratio (UACR) >30 mg/g.
Data sourced from ClinicalTrials.gov (NCT06003777). 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.