Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511, United States
NCT Number: NCT07172321
The purpose of this study is to see how different forms of a medicine called PF-08049820 move through the body when taken by mouth. The scientists want to see:
* How well is the medicine absorbed when it's made in different ways (fast vs. slow release) * If eating a high-fat meal changes how the medicine moves through the body The results of this study will help decide which version of the medicine is best for future studies.
This study is seeking participants who:
* are men and women who can't have children * are 18 years or older * weigh more than 99 pounds (45 kg) * have a healthy body weight (not too low or too high) * are generally healthy with no serious medical problems. People with serious health problems, recent drug use, or who had certain vaccines recently cannot join. * are willing to follow all the study rules
Each participant will try 5 different versions of the medicine, one at a time. There will be 3 days between each dose to make sure the medicine is out of the system. The medicine will be tested in different forms:
* Immediate-release tablet (works quickly) * Short-release tablet (works slowly) * Long-release tablet (works even slower)
Some versions will be taken without food, and others after eating a high-fat meal. After each dose, doctors will take blood samples for up to 72 hours to see how the medicine moves through the body. The whole study will take about 6 to 11 weeks and participants will stay overnight in the clinic for about 17 days.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06511, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally
Administered orally
Administered orally
Time frame: Pre-dose until 72 hours post dose
Time frame: Pre-dose until 72 hours post dose
Time frame: Pre-dose until 72 hours post dose
Time frame: Pre-dose until 72 hours post dose
Time frame: First dose, up to follow up visit (28-35 days post last dose)
Time frame: Baseline, up to Day 16
Time frame: Baseline, up to Day 16
Time frame: Baseline, up to Day 16
Pfizer
Industry
A Phase 1, Open-Label, Randomized, 5-Period, 6-Sequence, Crossover Study to Compare the Single-Dose Pharmacokinetics of One Immediate-Release and Two Modified-Release Formulations of PF-08049820 Administered Orally to Healthy Adult Participants Under Fasted and Fed Conditions
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06687512
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Ahmedabad, Gujarat, India
View Trial DetailsNCT05613062
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Hong Kong
View Trial DetailsNCT05633355
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Phoenix, Arizona, United States
View Trial DetailsNCT05899816
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Scottsdale, Arizona, United States
View Trial Details