Phase 1
Completed N=12
Study in Healthy Adults Evaluating PF-07202954
Source: ClinicalTrials.gov NCT04857437 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1 — 3; 0; 1; 2 Participants
Summary
The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1 |
3; 0; 1; 2; 1; 0 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 1 |
0; 2; 3; 6; 5; 3 | — |
| PRIMARY Number of Participants According to Categorization of Vital Signs Data: Part 1 |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With TEAEs: Part 2 |
— | — |
| PRIMARY Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 2 |
— | — |
| PRIMARY Number of Participants According to Categorization of Vital Signs Data: Part 2 |
— | — |
| PRIMARY Number of Participants According to Categorization of ECG Data: Part 2 |
— | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 3 |
— | — |
| PRIMARY Time for Cmax (Tmax) of PF-07202954: Part 3 |
— | — |
| PRIMARY Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 3 |
— | — |
| PRIMARY Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 3 |
— | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 1 |
23.92; 55.64; 226.6; 774.2; 2067; 195.7 | — |
| SECONDARY Time for Cmax (Tmax) of PF-07202954: Part 1 |
1.500; 0.7500; 3.000; 1.000; 1.750; 3.000 | — |
| SECONDARY Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 1 |
179.9; 402.1; 1905; 5506; 13850; 1834 | — |
| SECONDARY Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 1 |
185.6; 410.1; 1935; 5580; 13980; 1784 | — |
| SECONDARY Terminal Half-life (t1/2) of PF-07202954: Part 1 |
5.740; 5.615; 11.43; 10.55; 14.81; 15.85 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-07202954 on Day 1, 7 and 14: Part 2 |
— | — |
| SECONDARY Time for Cmax (Tmax) of PF-07202954 on Day 1, 7 and 14: Part 2 |
— | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 to Time Tau (AUCtau) of PF-07202954 on Day 1, 7 and 14: Part 2 |
— | — |
| SECONDARY Terminal Half-life (t1/2) of PF-07202954 on Day 14: Part 2 |
— | — |
| SECONDARY Amount of Unchanged Drug Recovered in Urine During Dosing Interval (Aetau) of PF-07202954 on Day 14: Part 2 |
— | — |
| SECONDARY Percent of Dose Recovered in Urine as Unchanged Drug Over Dosing Interval (Aetau%) on Day 14: Part 2 |
— | — |
| SECONDARY Renal Clearance (CLr) of PF-07202954 on Day 14: Part 2 |
— | — |
| SECONDARY Number of Participants With TEAEs: Part 3 |
— | — |
| SECONDARY Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 3 |
— | — |
| SECONDARY Number of Participants According to Categorization of Vital Signs Data: Part 3 |
— | — |
| SECONDARY Number of Participants According to Categorization of ECG Data: Part 3 |
— | — |
Eligibility Criteria
Inclusion Criteria:- healthy subjects (all 3 Parts)
- evidence of steatosis on FibroScan (Part 2 only)
- BMI 17.5 to 30.5 kg/m2 (Part 1, Part 3)
- BMI 17.5 to 35.4 kg/m2 (Part 2) Exclusion Criteria:- evidence of clinically significant disease
- subjects on chronic medications
- clinically significant, abnormal laboratory results, vital signs, or cardiac conduction abnormalities
- contraindication to MRI (Part 2, only)
Data sourced from ClinicalTrials.gov (NCT04857437). 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. Informational only — not medical advice.