A phase 1, open-label, 2-period, fixed sequence, study to investigate the absorption, metabolism and excretion of 14C-PF-06650833 and to assess the absolute bioavailability and fraction absorbed of PF-06650833 in healthy male subjects using a 14C-microdose approach.

A phase 1, open-label, 2-period, fixed sequence, study to investigate the absorption, metabolism and excretion of 14C-PF-06650833 and to assess the absolute bioavailability and fraction absorbed of PF-06650833 in healthy male subjects using a 14C-microdose approach. - A phase 1 study to investigate ADME and BA of 14C-PF-06650833.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44374

Enrollment

Registered

2017-11-13

Start date

2017-12-12

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

Rheumatoid Arthritis

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 55 years of age BMI 17.5 - 30.5 kilograms/meter2 Weight >50 kg

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 rates and extent of excretion of total radioactivity in urine and feces after single oral administration of 14C-PF-06650833-LR.	—

Secondary

Measure	Time frame
To identify the metabolites of PF-06650833 in plasma, urine and feces, if possible. To determine the pharmacokinetics of PF-06650833 following IV and oral administration of PF-06650833. To determine renal clearance of PF-06650833. To determine the safety and tolerability of PF-06650833 following simultaneous oral/IV administration.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)