NL-OMON45995CompletedNot Applicable
A Phase 1, Open-Label, Non-Randomized, 2-Period, Fixed Sequence Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14c-Pf-06700841] and to Assess the Absolute Bioavailability and Fraction Absorbed of Pf-06700841 in Healthy Male Subjects using a 14C-Microtracer Approach - PF-06700841 ADME microtracer study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer, Inc.
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1.Healthy male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and pulse rate (PR) measurement, 12-lead electrocardiogram (ECG), or clinical laboratory tests.;2.Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).;3.Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.;4.Subjects who are willing and able to comply with study confinement period, scheduled visits, treatment plan, laboratory tests, contraceptive requirements and other study procedures.
Exclusion Criteria
- •1.Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies).;2.Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).;3.Inability to have at least one bowel movement every 2 days on average.;4.A positive urine drug screen for drugs of abuse or recreational drugs.
Investigators
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