A phase 1, open label, 2-period, fixed sequence, study to assess the mass balance, absolute bioavailability of 14C-PF-06826647 in healthy male participants
- Conditions
- Psoriasis and ulcerative colitis1001796910003816
- Registration Number
- NL-OMON50100
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method