The purpose of this study is to investigate how safe the new compound PF-06700841 is and how well it is tolerated when it is administered to healthy volunteers. PF-06700841 has been administered to humans before. It will also be investigated how…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To characterize the rate and extent of radioactivity excretion of PF-06700841
and drug related material.
Secondary outcome
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.
Background summary
PF-06700841 is a new compound that may eventually be used for the treatment of
autoimmune and inflammatory diseases, such as psoriasis and inflammatory bowel
disease.
PF-06700841 is a, so-called, dual TYK2/JAK1 (tyrosine kinase 2 / janus kinase
1) inhibitor. TYK2 and JAK1 are each involved in different aspects of the
immune response. PF-06700841 suppresses both TYK2 and JAK1, and it is thought
that by suppressing multiple aspects of the immune response PF-06700841 will be
effective in treating various inflammatory diseases, such as psoriasis.
Study objective
The purpose of this study is to investigate how safe the new compound
PF-06700841 is and how well it is tolerated when it is administered to healthy
volunteers. PF-06700841 has been administered to humans before.
It will also be investigated how quickly and to what extent PF-06700841 is
absorbed and eliminated from the body . PF-06700841 will be labelled with 14
Carbon (14C) and is thus radioactive.
In addition, the taste of the oral solution of PF-06700841 will be assessed.
Study design
The actual study will consist of 2 periods. During the first period the
subjects will stay in the research center for a minimum of 6 days (5 nights)
and maximum of 15 days (14 nights). During the second period the subjects will
stay in the research center for a minimum of 6 days (5 nights) and a maximum of
8 days (7 nights). The second period will start 16 days after administration of
the study compound in the first period.
Because of logistical reasons (discharge will be based on outsourced laboratory
results) the chance is very high the subjects have to stay at the research
center for a minimum for at least 8 days (7 nights) in both periods.
In each period, Day 1 is the first day of administration of the study compound.
In both periods the subjects are expected at the research center at 14:00 h in
the afternoon prior to the day of administration of the study compound (Day
-1).
In the first period the subjects will be given 60 mg 14C (radiolabeled)
PF-06700841 as a drink of 240 milliliters (mL). the subjects will have to fill
out a taste assessment questionnaire immediately after drinking the solution
with the study compound, and again after 5, 10 and 20 minutes.
In the second period the subjects will be given 60 mg (non-radiolabeled)
PF-06700841 as a drink of 240 mL, similar as in period 1. About 1 hour after
the drink, the subjects will receive 30 µg 14C PF-06700841 and as an
intravenous infusion (solution of the compound that will be administered
directly in a blood vessel). The infusion will last about 5 minutes.
Intervention
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-06700841 as a drink of 240 mL, similar as in period 1. About 1 hour after
the drink, the subjects will receive 30 µg 14C PF-06700841 and as an
intravenous infusion (solution of the compound that will be administered
directly in a blood vessel).
Study burden and risks
Drawing blood and/or insertion of the indwelling cannula may be painful or
cause some bruising.
In total, we will take about 477 mL of blood. This amount does not cause any
problems in adults. To compare: a blood donation involves 500 mL of blood being
taken each time.
To make a heart tracing, electrodes (small, plastic patches) will be pasted at
specific locations on the arms and legs. Prolonged use of these electrodes can
cause skin irritation (rash and itching).
East 42nd Street 235
New York NY 10017
US
East 42nd Street 235
New York NY 10017
US
Listed location countries
Age
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
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
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 | EUCTR2018-002403-34-NL |
| CCMO | NL67100.056.18 |