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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45995

Enrollment

Registered

2018-11-05

Start date

2018-12-10

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Interventions

In the first period the subjects will be given 60 mg 14C (radiolabeled) PF-06700841 as a drink of 240 milliliters (mL). In the second period the subjects will be given 60 mg (non-radiolabeled) PF-

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To characterize the rate and extent of radioactivity excretion of PF-06700841 and drug related material.	—

Secondary

Measure	Time frame
To identify the metabolites of PF-06700841 in plasma, urine and feces, if possible. To determine the pharmacokinetics of PF-06700841 following oral administration of PF-06700841 and 14C-PF-06700841 following IV administration of 14C-PF-06700841, and of total 14C in plasma following oral 14C-PF-06700841. To determine the oral absolute bioavailability (F) of PF-06700841 in solution following single dose administration under fasted condition. To determine the fraction of PF-06700841 dose absorbed (Fa). To determine the safety and tolerability of PF-06700841 following simultaneous oral/IV administration.	—

Measure

Time frame

To identify the metabolites of PF-06700841 in plasma, urine and feces, if possible. To determine the pharmacokinetics of PF-06700841 following oral administration of PF-06700841 and 14C-PF-06700841 following IV administration of 14C-PF-06700841, and of total 14C in plasma following oral 14C-PF-06700841. To determine the oral absolute bioavailability (F) of PF-06700841 in solution following single dose administration under fasted condition. To determine the fraction of PF-06700841 dose absorbed (Fa). To determine the safety and tolerability of PF-06700841 following simultaneous oral/IV administration.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)