Phase 1
Completed N=29
A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants
Healthy Participants
Source: ClinicalTrials.gov NCT04628793 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 6; 0; 0; 1 Participants
Summary
This study will be the first time PF-07258669 is administered to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-07258669 following administration of single oral doses to healthy adult participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
6; 0; 0; 1; 2; 1 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality) |
14; 5; 3; 4; 4; 6 | — |
| PRIMARY Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of PF-07258669 |
0.8439; 3.053; 10.72; 26.48; 53.30; 188.1 | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07258669 |
2.421; 7.826; 27.83; 75.84; 182.2; 584.8 | — |
| SECONDARY Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-07258669 |
2.659; 8.252; 28.55; 76.63; 183.0; 586.9 | — |
| SECONDARY Time for Cmax (Tmax) of PF-07258669 |
1.00; 1.00; 0.750; 0.750; 1.00; 1.00 | — |
| SECONDARY Terminal Half-life (t1/2) of PF-07258669 |
2.508; 3.828; 4.572; 5.013; 5.558; 6.698 | — |
Eligibility Criteria
Inclusion Criteria
- Female participants of non-child bearing potential and male participants and who are overtly healthy as determined by medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring.
- Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor, as appropriate.
- 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 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), as well as presence of lipid panel abnormalities (eg, hypercholesterolemia, hypertriglyceridemia).
- Evidence of history of orthostatic hypotension or symptomatic bradycardia.
- 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 drug 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).
- Current findings or documented past history of blood pressure values <90 mmHg systolic or <50 mmHg diastolic.
- Any lipid panel parameter (ie, total cholesterol, triglycerides, HDL, and/or LDL) ≥1.25× ULN.
Data sourced from ClinicalTrials.gov (NCT04628793). 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.