A Study for Multiple Tablet Forms of The Study Medicine (PF-07220060) in Healthy Adults
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Drug: Single dose of PF-07220060 as first Tablet FormulationDrug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administrationDrug: Single dose of PF-07220060 as third tablet formulationDrug: Single dose of PF-07220060 as second Tablet FormulationDrug: Single dose of PF-07220060 as a Tablet Formulation
- Registration Number
- NCT05923411
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to compare multiple formulations of PF-07220060 in terms of their uptake into the blood stream. The study will assess the effects of food and Rabeprazole on the uptake of PF-07220060. Rabeprazole belongs to a type of medications called proton pump inhibitors. In reality, some patients may take both PF-07220060 and rabeprazole together.
This study is seeking participants that are:
- Healthy male or female aged 18 to 65 years
Participants in this study will receive PF-07220060 once or twice by mouth. The participants may receive different tablets for PF-07220060. Some participants will take a meal before receiving PF-07220060. In addition, some participants will take rabeprazole by mouth for 7 days before taking PF-07220060.
The study will compare experiences of people receiving different formulations of PF-07220060. Experiences of people taking food and rabeprazole with PF-07220060 will be compared to those on PF-07220060 alone. This will help understand how much PF-07220060 is taken up into the blood. It will also help understand how meal and Rabeprazole medicine changes the uptake of PF-07220060 into the blood.
Participants will take part in the study for a maximum of 74 days. During this time, they will have to stay onsite for 5 to 13 days. There will be up to 2 onsite study visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
Inclusion Criteria
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- BMI of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
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), or hepatitis B surface antigen (HCVAb). Hepatitis B vaccination is allowed.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Prior/Concomitant Therapy:
- 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 exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
- A positive urine drug test/urine cotinine test.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 Single dose of PF-07220060 as first Tablet Formulation Participants will receive PF-07220060 tablet by mouth Cohort 6 Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration Participants will receive PF-07220060 and Rabeprazole tablets by mouth Cohort 8 Single dose of PF-07220060 as third tablet formulation Participants will receive PF-07220060 tablet by mouth Cohort 1 Single dose of PF-07220060 as first Tablet Formulation Participants will receive PF-07220060 tablet by mouth Cohort 2 Single dose of PF-07220060 as second Tablet Formulation Participants will receive PF-07220060 tablet by mouth Cohort 4 Single dose of PF-07220060 as second Tablet Formulation Participants will receive PF-07220060 tablet by mouth Cohort 5 Single dose of PF-07220060 as a Tablet Formulation Participants will receive PF-07220060 tablet by mouth Cohort 7 Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration Participants will receive PF-07220060 and Rabeprazole tablet by mouth
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time(AUCinf) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
- Secondary Outcome Measures
Name Time Method Number of Participants With Laboratory Abnormalities From baseline up to 28 days after PF-07220060 dose Number of Participants With Clinically Significant Change From Baseline in Vital Signs From baseline up to 28 days after PF-07220060 Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time(AUCinf) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations (third formulation) 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours PF-07220060 post-dose AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings From baseline up to 28 days after PF-07220060 Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) From baseline up to 28 days after PF-07220060 dose Cmax of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose AUCinf of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose AUCinf of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations (third formulation) 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours PF-07220060 post-dose Cmax of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
Trial Locations
- Locations (1)
New Haven Clinical Research Unit
🇺🇸New Haven, Connecticut, United States