Psoriasis and ulcerative colitis
Conditions
Interventions
In Period 1 on Day 1, volunteer will be given 600 mg of 14C-labeled PF-06826647
as a drink of 100 mL. After administration of the study compound, the cup will
be rinsed 3 times with 47 mL of water,
Sponsors
Pfizer Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD. 2. Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including BP and pulse rate measurement, laboratory tests, and 12-lead ECG. 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 4. BMI of 17.5 to 30.0 kg/m2; and a total body weight >50 kg (110 lb). 5. Capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
Exclusion criteria: 1. 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). 2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). 3. History of irregular bowel movements including irritable bowel syndrome or frequent episodes of diarrhea or constipation defined by less than 1 bowel movement on average per 2 days or lactose intolerance. 4. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed. -For hepatitis B, all participants will undergo testing for HBsAg and HBcAb during screening. Participants who are HBsAg positive will not be eligible for this study. Participants who are HBsAg negative but HBcAb positive will be reflex tested for HBsAb. The participant will be eligible if HBsAb is positive. -For hepatitis C, all participants will undergo testing for HCVAb during screening.Participants who are HCVAb positive will be reflex tested for hepatitis C ribonucleic acid (HCV RNA). Participants who are HCVAb and HCV RNA positive are not eligible for the study. Participants who are HCVAb positive but HCV RNA negative will be considered eligible. 5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator*s judgment, make the participant inappropriate for the study. 11. A positive COVID-19 test or suspected of having SARS-CoV2 infection. Further criteria apply, referring to protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total recovery of radioactivity in urine and feces separately, and both routes combined, expressed as a percent of total oral radioactive dose administered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: laboratory tests, AE reporting, ECG and vital signs. The ratio of dose normalized AUCinf of PF-06826647 (LCMS) and 14C-PF-06826647 (AMS) in plasma in Period 2. | — |
Countries
Netherlands
Outcome results
None listed