A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF SINGLE ASCENDING ORAL DOSES OF PF-08057418 IN HEALTHY ADULT PARTICIPANTS
Pfizer
Summary
The purpose of this clinical trial is to learn about the safety and pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from body after participant take it) of the study medicine (called PF-08057418) in healthy people. This study is seeking participants who are healthy adults. Everyone who participates in this study will receive the study medicine. The study medicine may be given as a solution or as a tablet. Participants will be dosed once a week for 5 weeks. The investigator will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe. Participants will be involved in this study for up to 13 weeks from screening to follow-up visit. Participants stay in the study clinic for the 5 week dosing duration of the study, with two follow-up visits subsequently, either in person or by telephone call.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Adults 18 to 60 years of age (or the minimum age of consent per local regulations) at screening. * Healthy participants, as determined by medical history, physical examination, clinical laboratory tests, and cardiac monitoring. * Body mass index (BMI) between 16 and 32 kg/m² and body weight \>50 kg (110 lb). * Willing and able to comply with all study procedures, including scheduled visits, treatment plans, laboratory testing, and lifestyle restrictions. Exclusion Criteria: * History or evidence of clinically significant medical conditions, including but not limited to…
Interventions
- DrugPF-08057418
solution or tablet (fasted/fed)
- OtherPlacebo (A placebo does not have any medicine in it but looks just like the medicine being studied.)
solution or tablet (fasted/fed)
Location
- Pfizer Clinical Research Unit -New HavenNew Haven, Connecticut