A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961
- Conditions
- diabetes10018424
- Registration Number
- NL-OMON49480
- Lead Sponsor
- Pfizer, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Age and Sex:
1. Male participants must be 18 to 54 years of age, inclusive, at the time of
signing the
informed consent document (ICD).
Type of Participant and Disease Characteristics:
2. Male participants who are overtly healthy as determined by medical
evaluation including medical history, physical examination, laboratory tests,
and ECG.
3. Participants who are willing and are able to comply with all scheduled
visits, treatment plan, laboratory tests, lifestyle considerations, and other
study procedures.
Weight:
4. Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight >=50 kg
(110 lb).
Informed Consent:
5. Capable of giving signed informed consent as described in the protocol,
which includes compliance with the requirements and restrictions listed in the
informed consent document (ICD) and in this protocol.
Medical Conditions:
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 (eg, irritable bowel syndrome or
frequent episodes of diarrhea or constipation) or lactose intolerance.
4. Other acute or chronic medical or psychiatric condition including recent
(within the past year) or active suicidal ideation or behavior or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation
of study results and, in the judgment of the investigator, would make the
participant inappropriate for entry into
this study.
Prior/Concomitant Therapy:
5. Use of prescription or non-prescription drugs and dietary and herbal
supplements within 14 days prior to the first dose of investigational product.
(Refer to Section 6.5 for additional details). As an exception, ibuprofen or
acetaminophen may be used at doses of <=1 g/day. Limited use of non-prescription
medications that are not believed to affect participant safety or the overall
results of the study may be permitted on a case-by-case basis following
approval by the sponsor.
Prior/Concurrent Clinical Study Experience:
6. Previous administration with an investigational drug within 60 days (or as
determined by the local requirement) preceding the first dose of
investigational product used in this study.
7. Known prior participation in a trial involving PF-06882961 or known
intolerance to a GLP-1R agonist.
Further criteria apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Total recovery of radioactivity in urine and feces, and both routes combined,<br /><br>expressed as a percent of total oral radioactive dose administered.</p><br>
- Secondary Outcome Measures
Name Time Method