Phase 1
Completed N=12
A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers
Healthy
Source: ClinicalTrials.gov NCT06122194 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of PF-07817883 — 2308; 2579; 4266; 3566 nanogram per milliliter (ng/mL)
Summary
The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of PF-07817883 |
2308; 2579; 4266; 3566 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883 |
17660; 18200; 21040; 21510 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
2; 2; 3; 2 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
1; 0; 1; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormality in Vital Signs |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG) |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants aged 18 years or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
- BMI of 16 to 32 kg/m2; and a total body weight >45 kg
- Capable of giving signed informed consent.
Exclusion Criteria
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality, or other conditions and situations that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- 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).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
- Positive test result for SARS-CoV-2 infection at admission
Data sourced from ClinicalTrials.gov (NCT06122194). 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.