A Study to Learn How the Medicine Called [14C] PF-06821497 is Taken up Into and Removed From the Body.

Launched by PFIZER · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to understand how a medicine called [14C] PF-06821497 is absorbed into the bloodstream and how the body gets rid of it. To do this, the study will involve healthy adult males aged 18 and older who weigh more than 50 kilograms. Participants will need to pass medical tests to confirm they are healthy. The trial consists of two parts: in the first part, participants will take one full dose of the medicine by mouth, and in the second part, they will take another full dose by mouth along with a smaller dose given directly into the vein through an IV.

Participants will be involved in the study for about 11 weeks, during which they will have blood, urine, and stool samples collected after each dose. This will help researchers compare how much of the medicine enters the bloodstream when taken by mouth versus through the IV and understand how the body removes it. It's important for participants to be available for all visits and follow the study's guidelines. Overall, this study aims to gather valuable information that could help in understanding how this new medicine works in the body.

Gender

MALE

Eligibility criteria

• Key eligibility criteria for this study include, but are not limited to the following:
• Inclusion Criteria:
• • Male participants aged 18 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• • Body mass index (BMI) of 16-32 kg/m2; and a total body weight of \>50kg (110lb)
• • Participants who are willing to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
• Exclusion Criteria:
• • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, prior bariatric surgery, ileal resection, inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease).
• • Chronic liver diseases including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus, or other chronic liver disease.
• • Previous administration with an investigational product (drug or vaccine) 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). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
• • Total \[14C\] radioactivity measured in plasma at screening exceeding 11 mBq/mL