Phase 1
N=30
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05431153 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C — 10920; 10720; 11200 Nanograms*hour per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Single dose of PF-07104091 as Tablet Formulation A (Treatment A) (Drug); Single dose of PF-07104091 as Tablet Formulation B (Treatment B) (Drug); Single dose of PF-07104091 as Tablet Formulation C (Treatment C) (Drug); Single dose of PF-07104091 as Tablet Formulation D (Treatment D) (Drug); Single dose of PF-07104091 as Tablet Formulation C (Treatment E) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C |
10920; 10720; 11200 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C |
1531; 1490; 1415 | — |
| SECONDARY AUCinf of PF-07104091 for Treatment C, D and E |
11200; 12850; 10500 | — |
| SECONDARY Cmax of PF-07104091 for Treatment C, D and E |
1415; 1498; 1193 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs |
21; 19; 17; 7; 2; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
0; 0; 1; 3; 1 | — |
| SECONDARY Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Meaningful Findings in Vital Signs |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments |
0; 0; 0; 0; 0 | — |
Summary
This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.
Eligibility Criteria
Inclusion Criteria
- Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12 lead ECGs.
- Body-Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of >50 kg (110 lb).
- Written evidence of a personally signed and dated informed consent document (ICD) indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
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).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAB) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- 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.
- A positive urine drug test.
- History of sensitivity to heparin or heparin induced thrombocytopenia.
Data sourced from ClinicalTrials.gov (NCT05431153). 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.