The purpose of this study is to investigate how quickly and to what extent PF-06650833 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). PF-06650833 is not registered as a drug, but…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
PF-06650833 is a new compound that may eventually be used for the treatment of
Rheumatoid Arthritis (RA), which is an autoimmune disease. PF-06650833 is a
so-called interleukin-1 receptor-associated kinase 4 (IRAK 4) inhibitor. This
means that PF-06650833 is able to inhibit the activity of certain enzymes
inside cells, including white blood cells. This will ultimately lead to the
inhibition of the production of inflammatory proteins by these white blood
cells. As a result, there may be a decrease in inflammatory processes that are
characteristic for RA.
Study objective
The purpose of this study is to investigate how quickly and to what extent
PF-06650833 is absorbed, distributed, metabolized (broken down) and eliminated
from the body (this is called pharmacokinetics). PF-06650833 is not registered
as a drug, but has been given to humans before.
Part of the PF-06650833 to be administered will be labeled with 14 Carbon (14C)
and is thus radioactive (also called radiolabeled). In this way PF-06650833 can
be traced in blood, urine and feces. The amount of radioactivity will be
negligible. It will also be investigated how PF-06650833 is tolerated. In
addition, the taste of PF-06650833 will be investigated.
Study design
The study consists of 2 periods. In the first period (Period A) the volunteers
will receive 300 mg 14C radiolabeled PF-06650833 as an oral solution with tap
water to a volume of 240 mL. In the second period (Period B) they will receive
300 mg unlabeled PF-06650833 as an oral solution in tap water to a volume of
240 mL. Two hours later they will receive 10 mL 14C radiolabeled PF-06650833 as
an intravenous infusion over 5 minutes.
When PF-06650833 is administered, they should have fasted for at least 8 hours
(no eating and drinking). Also after administration of the study compound, they
will be required to fast for 4 additional hours. Then they will be served
lunch. During fasting the volunteers are allowed to drink
water, except during 1 hour before and 1 hour after administration of the study
compound (for Period B: after the intravenous infusion).
Intervention
Not applicable.
Study burden and risks
Pain, minor bleeding, bruises and possibly an infection.
East 42nd Street 235
New York NY 10017
US
East 42nd Street 235
New York NY 10017
US
Listed location countries
Age
Inclusion criteria
healthy male subjects
18 - 55 years of age
BMI 17.5 - 30.5 kilograms/meter2
Weight >50 kg
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-002044-32-NL |
| CCMO | NL63629.056.17 |