In this study we will investigate how safe the new compound REC-4881 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent REC-4881 is absorbed, transported, and eliminated from…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Colon cancer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the safety and tolerability of single ascending doses (SADs) of
orally administered REC-4881 in healthy adult volunteers.
Secondary outcome
To characterize the plasma pharmacokinetics (PK) of SADs of orally administered
REC-4881 and REC 1157786 (its enantiomer) in healthy
adult volunteers.
To evaluate the effect of food on the single-dose PK of REC-4881 and REC
1157786.
Background summary
REC-4881 is a new compound that may potentially be used for the treatment of
inherited colon cancer. REC-4881 inhibits mitogen activated protein kinase
(MEK), an enzyme involved in normal functioning of human cells. In a healthy
individual MEK can regulate cell division at a normal rate. In tumors MEK is
overactivated and causes excessive cell division and growth. From studies in
animals it is known that REC-4881 can counter this process. REC-4881 can
possibly be used in the future for the treatment of inherited colon cancer in
patients.
Study objective
In this study we will investigate how safe the new compound REC-4881 is and how
well it is tolerated when it is used by healthy participants.
We also investigate how quickly and to what extent REC-4881 is absorbed,
transported, and eliminated from the body. In addition, we look at the effect
of REC-4881 on a specific enzyme.
For Group 1: In addition, we will look at the effect of food on how the body
handles REC-4881. To study this, the study compound will be given once with and
once without food. Depending on these results, thereafter, a higher dose of REC
4881 will be given either with or without food.
We compare the effects of REC-4881 with the effects of a placebo. A placebo is
a compound without any active ingredient. Please note that when the term *study
compound* is used in this document, we mean REC-4881, placebo, or both.
REC-4881 has been used by humans before. In addition, it has been extensively
tested in the laboratory and on animals. REC-4881 will be tested at various
dose levels.
Study design
For Group 1, the study takes about 9 weeks from the inspection to leaving the
research center. For Group 2, the study from the inspection up to and including
leaving the research center takes a maximum of approximately 10 weeks.
For the study, it is necessary for Group 1 and Group 2 to stay in the study
center for a period of 37 days (36 nights).
Day 1 is the first day of receiving the study drug. We expect the volunteer at
the study center on the day prior to the first administration of the study
drug. You must report to the research center between 9:30 a.m. and 2:00 p.m.
One will leave the study center on Day 36 (Group 1) or Day 28 (Group 2) of the
study.
Group 1 will receive three times REC-4881 or placebo as capsules by mouth
containing 240 milliliters (mL) of (tap) water. REC-4881 is given twice as a 4
mg dose and once as a 8 mg dose.
Group 2 will receive REC-4881 or placebo three times as capsules by mouth
containing 240 milliliters (mL) (tap) of water. REC-4881 is given once as a 4
mg dose, once a 8mg dose and once as a 12 mg dose.
Intervention
Group 1:
Treatment
4 mg REC-4881 once or placebo (with food or fasting) Days 1 and 15
8 mg REC-4881 once or placebo (with food or fasted) Day 29
Group 2:
Treatment
4 mg REC-4881 once or placebo (with food or fasting) Days 1
8 mg REC-4881 once or placebo (with food or fasting) Days 15
12 mg REC-4881 once or placebo (with food or fasting) Days 29
Study burden and risks
blood draw
Blood draws may hurt or cause bruising. Using an indwelling cannula can
sometimes cause inflammation, swelling, hardening of the artery, or blood
clotting and bleeding around the puncture site. In some individuals, a blood
draw can sometimes cause paleness, nausea, sweating, slow heart rate, or drop
in blood pressure with dizziness or fainting.
All in all, we take approximately 263 milliliters (ml) of blood from the
examination until you leave the research center if you participate in both
Group 1 and in Group 2. This amount is not a problem in adults. For
comparison: at the blood bank 500 ml of blood is taken at once at a time. If
the investigator deems this necessary to ensure the safety of the participant,
additional samples may be taken for any additional testing. If this happens,
the total amount of blood drawn may be more than the amount indicated above.
ECG
To make a heart film, electrodes are placed on the arms, chest and legs. To
monitor the electrical activity of the heart over a longer period of time,
electrodes are placed on the chest and abdomen. Prolonged use of these
electrodes may cause skin irritation.
Meals/Fasting
The high-fat breakfast is a large breakfast, including 2 fried eggs, hash
browns and bacon. One must eat this breakfast completely. Especially for small
eaters, it can be difficult to eat this breakfast completely.
If one has to fast for a long time during the examination, this can lead to
complaints such as dizziness, headache, stomach complaints or fainting.
Coronavirus test
Samples for the coronavirus test will be taken with cotton swabs at the back of
the nose and throat. Collecting the samples only takes a few seconds, but can
cause discomfort and discomfort. Taking a sample from the back of the throat
may result in gagging. When the sample is taken from the back of the nose, you
may experience a stinging sensation and the eyes may water.
41 S Rio Grande St. 41
Salt Lake City UT 84101
US
41 S Rio Grande St. 41
Salt Lake City UT 84101
US
Listed location countries
Age
Inclusion criteria
1. Male or female participant aged 18 to 50 years, inclusive.
2. Participant must provide written informed consent.
3. Participant's body mass index is between 18 and 32 kg/m2, inclusive, with a
minimum body weight of 50 kg.
4. Participant is healthy, as determined by pre-study medical history,physical
examination (including neurologic examination), vital signs, and 12-lead ECG.
Exclusion criteria
1. Participant has any clinically significant laboratory abnormality or illness
which, in the opinion of the Investigator, could interfere with the conduct or
interpretation of the study or put the participant at risk.
2. Participant has a history of gall bladder disorder or complication,
including cholelithiasis.
3. Participant has a history of abnormal left ventricular ejection fraction.
4. Participant has a history of corneal erosions, corneal degenerations, active
or recurrent keratitis, and other forms of serious ocular surface inflammatory
conditions.
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 | EUCTR202100690930-NL |
| CCMO | NL80312.056.22 |