A phase 1, open-label, non-randomized, 2-period, fixed sequence study to investigate the absorption, metabolism and excretion of [14C-PF-04965842] and to assess the absolute bioavailability and fraction absorbed of PF-04965842 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, metabolism and excretion of [14C-PF-04965842] and to assess the absolute bioavailability and fraction absorbed of PF-04965842 in healthy male subjects using a 14C-microtracer approach. - A phase 1 study to investigate ADME and BA of [14C-PF-04965842].

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45258

Enrollment

Registered

2017-06-30

Start date

2017-07-10

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

eczeem auto-immune disease eczema

Interventions

Not applicable.

eczema (atopic dermatitis)

JAK1 inhibitor

PF 04965842

systemic lupus erythematosus (SLE)

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 55 years, inclusive BMI 17.5 - 30.5 kilograms/meter2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To characterize the rate and extent of radioactivity excretion of PF-04965842 and drug related material.	—

Secondary

Measure	Time frame
To identify the metabolites of PF-04965842 in plasma, urine and feces, if possible. To determine the pharmacokinetics of PF-04965842 following IV and oral administration of PF-04965842. To determine the oral absolute bioavailability (F) of PF-04965842 following single dose administration under fasted condition. To determine the fraction of PF-04965842 dose absorbed (Fa). To determine the safety and tolerability of PF-04965842 following simultaneous oral/IV administration.	—

Measure

Time frame

To identify the metabolites of PF-04965842 in plasma, urine and feces, if possible. To determine the pharmacokinetics of PF-04965842 following IV and oral administration of PF-04965842. To determine the oral absolute bioavailability (F) of PF-04965842 following single dose administration under fasted condition. To determine the fraction of PF-04965842 dose absorbed (Fa). To determine the safety and tolerability of PF-04965842 following simultaneous oral/IV administration.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)