diabetes
Conditions
Interventions
In Period 1 on Day 1 subjects will be given PF-06882961 with the radioactive
label as a drink of 100 mL.
In Period 2 on Day 1 subjects will be given PF-06882961 without the radioactive
label as a
Sponsors
Pfizer, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C]PF-06882961 in plasma, urine, and feces. AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and plasma elimination half-life (t*) to describe single oral dose PK of: * Total radioactivity in plasma; * PF-06882961 in plasma. Parameters to describe intravenous plasma PK: AUClast, AUCinf, t*, MRT, CL & Vss. Absolute oral bioavailability (F) computed from plasma AUCinf of oral unlabeled PF-06882961 in Period 2 and intravenous microtracer of [14C]PF-06882961 in Period 2. Fraction absorbed calculated from ratio of total urinary radioactivity following oral administration of [14C]PF-06882961 in Period 1 and intravenous administration of [14C]PF-06882961 in Period 2. Safety endpoints including physical examinations, adverse events, clinical laboratory measurements, vital signs, and ECG. | — |
Countries
Netherlands
Outcome results
None listed