Obesity Type 2 Diabetics
Conditions
Interventions
Period 1, Day 1, 30 milligram (mg) radioactively-labeled PF 07081532 in a 100
mL solution as a drink, once
Period 2, Day 1, 30 mg PF-07081532 in a 100 mL solution as a drink, once
Period 2, Day 1, 10
Sponsors
Pfizer
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male participants must be 18 to 60 years of age, inclusive, at the time of signing the ICF. 2. Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure and pulse rate measurement, standard 12-lead ECG, and laboratory tests. 3.BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
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). • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). • Positive testing at screening for HIV, HBsAg, HBcAb, HBsAb or HCVAb. Note: A positive HBsAb due to hepatitis B vaccination is permissible. 2. Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator*s judgement. 3. History of irregular bowel movements (eg, irritable bowel syndrome, frequent episodes of diarrhea, or constipation defined by less than 1 bowel movement on average per 2 days) or lactose intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To characterize the extent of excretion of total radioactivity in urine and feces following administration of a single oral dose of [14C]PF-07081532. • To characterize the metabolic profile and identify circulating and excreted metabolites following administration of a single oral dose of [14C]PF-07081532. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To quantify plasma PK parameters of PF-07081532 and total radioactivity following administration of a single oral dose of [14C]PF-07081532. • To quantify plasma PK parameters of [14C]PF-07081532, following administration of a single, IV, microdose of [14C]PF-07081532. • To determine the absolute oral bioavailability (F) of PF-07081532 following administration of a single oral dose of PF-07081532 compared to a single IV microdose of [14C]PF-07081532. • To determine the fraction of dose absorbed (Fa) following administration of a single oral dose of [14C]PF-07081532. • To evaluate safety and tolerability of PF-07081532, administered as a single oral dose of [14C]PF-07081532 or a single oral dose of PF-07081532 followed by administration of a single IV microdose of [14C]PF-07081532. | — |
Countries
Netherlands
Outcome results
None listed