The purpose of the study is to investigate how quickly and to what extent PF 04965842 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). A small part of the PF 04965842 to be…
ID
Source
Brief title
Condition
- Other condition
- Autoimmune disorders
Synonym
Health condition
eczeem
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To characterize the rate and extent of radioactivity excretion of PF-04965842
and drug related material.
Secondary outcome
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.
Background summary
PF 04965842 is a new investigational compound that may eventually be used for
the treatment of eczema (atopic dermatitis) and systemic lupus erythematosus
(SLE), which is an autoimmune disease. PF 04965842 is a so-called Janus kinase
1 (JAK1) inhibitor. This means that PF 04965842 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 eczema and SLE. PF 04965842 is in
development and is not registered as a drug but has been given to humans
before.
Study objective
The purpose of the study is to investigate how quickly and to what extent PF
04965842 is absorbed, distributed, metabolized (broken down) and eliminated
from the body (this is called pharmacokinetics). A small part of the PF
04965842 to be administered will be labeled with 14 Carbon (14C) and is thus
radioactive (also called radiolabeled). In this way PF 04965842 can be traced
in blood, urine and feces. The amount of radioactivity is negligible as
explained in Section *How much radiation will I be exposed to in this study?*.
It will also be investigated to what extent PF 049658421234 is tolerated. In
addition, the taste of PF 04965842 will be investigated.
This study will be performed in approximately 6 healthy male volunteers.
Study design
The actual study will consist of 2 periods. During the first period the
volunteers will stay in the clinical research center in Groningen (location
UMCG Hospital) for a minimum of 8 days (7 nights) and a maximum of 15 days (14
nights). During the second period they will stay in the clinical research
center in Groningen (also at the location UMCG) for 8 days (7 nights). They
will be contacted by phone for a follow-up at approximately 28 days after they
have received the study compound for the last time. The time interval between
the days on which they will receive the study compound is 10 to 17 days,
depending on the day they will leave the clinical research center.
In each period, Day 1 is the day of administration of study compound. In both
periods, the volunteers are expected at the clinical research center at 14:00 h
in the afternoon prior to the day of administration of the study compound.They
will be required not to have consumed any food or drinks during the 4 hours
prior to arrival in the clinical research center (with the exception of water).
They will leave the clinical research center between Day 7 and Day 14 in the
first period and on Day 7 in the second period. If in the first period, from
Day 6 onwards, the radioactivity levels in urine and feces are below the
pre-defined levels, they will be allowed to leave the clinical research center
earlier (thus before Day 14 in the first period).
They will be contacted by phone on Day 28 of the second period for a follow-up.
The participation to the entire study, from the pre-study screening until the
follow-up phone call will be a maximum of 12 weeks.
Intervention
Not applicable.
Study burden and risks
Pain, minor bleeding, bruises and possibly an infection.
East 42nd Street, 235
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East 42nd Street, 235
New York NY 10017
US
Listed location countries
Age
Inclusion criteria
healthy male subjects
18 - 55 years, inclusive
BMI 17.5 - 30.5 kilograms/meter2, inclusive
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 | EUCTR2017-000461-73-NL |
CCMO | NL61396.056.17 |