The study will be performed in 3 parts, Parts 1, 2 and an optional Part 3. The purpose of the study is to investigate to what extent ODM-108 is tolerated. It will also be investigated how quickly and to what extent ODM-108 is absorbed and eliminated…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Neuropathische pijn.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of Part I is to evaluate the safety and tolerability of
single escalating doses of ODM-108 compared to placebo.
The primary objective of Part II is to evaluate the safety and tolerability of
repeated, escalating doses of ODM-108 compared to placebo.
The primary objective of optional Part III is to evaluate the effect of ODM-108
on CYP3A4 activity.
Secondary outcome
To determine the dose-effect of ODM-108 on the intensity of spontaneous pain,
on the area of secondary hyperalgesia and the area of flare in response to
intradermal capsaicin during Parts I and II.
To determine the dose-effect of ODM-108 on the intensity of spontaneous pain,
on the area of secondary hyperalgesia, and the area of flare in response to
topical mustard oil during Part II.
*
To evaluate the pharmacokinetic profile of ODM-108 and any putative metabolites.
To evaluate the effect of a standard breakfast on ODM-108 with respect to the
pharmacokinetic profile of ODM-108 and metabolites during Part II.
To evaluate the effect of ODM-108 on the subjective assessment of sedation in
Parts I and II, and on a concise battery of psychomotor tests and body sway
during Part II.
To evaluate the effect of ODM-108 on CYP3A4 hepatic enzyme induction, as
assessed by the biomarkers 6*-hydroxycortisol/total cortisol and 4*-
hydroxycholesterol during Part II of the study
Background summary
ODM-108 is a new investigational compound that may eventually be used for the
treatment of neuropathic pain. Neuropathic pain is pain caused by the damage of
a nerve. ODM 108 is a molecule that specifically recognizes, binds and blocks
the function of the TRPA1 receptor. A receptor is a protein on the surface of a
cell to which a signaling molecule can bind, causing a change in the activity
of the cell. TRPA1 receptors are present in neurons that sense pain and play an
important role in pain signaling.
Study objective
The study will be performed in 3 parts, Parts 1, 2 and an optional Part 3. The
purpose of the study is to investigate to what extent ODM-108 is tolerated. It
will also be investigated how quickly and to what extent ODM-108 is absorbed
and eliminated from the body (this is called pharmacokinetics). In addition,
the effect of the compound on the sensation of pain and on cognition
(activities of thinking, understanding, learning, and remembering) will be
investigated (this is called pharmacodynamics). This study will be performed in
healthy male volunteers.
Study design
Before the study the volunteers will undergo a pre-study screening during which
they will be subjected to a number of medical examinations. Similar
examinations will be performed after the study at the post-study screening.
They undergo up to 3 additional screening visits:
The volunteers will undergo an additional screening visit during which they
will undergo a pain test. The volunteers will have to wear a portable device
called a Holter monitor that will continuously monitor their cardiac function
for 24 hours. The volunteers will have to return to the clinic after 24 hours
to return the Holter monitor. Finally, there will be an additional screening
visit during which they will undergo an EEG in the Martini Hospital in
Groningen.
The actual study will consist of 1 period during which the volunteers will stay
in the clinical research center in Groningen for 6 days (5 nights).
The volunteers will leave the clinical research center on Day 5.
During the study the volunteers will receive ODM-108 or placebo after an
overnight fast (at least 10 hours) as capsules with 240 milliliters of tap
water. They are not allowed to chew on or divide the capsules before
swallowing.
For all groups it is applicable that fasting will continue until 4 hours after
drug administration. Then they will receive a lunch. During fasting and after
intake of the study compound, they are allowed to drink water with the
exception of 1 hour prior to study drug administration. During the first 4
hours after intake of the study compound, the volunteers are allowed to drink
200 ml of water every 2 hours.
One of the investigators will inspect the hands and mouth after study compound
intake.
Intervention
n.a.
Study burden and risks
During the investigation, various assessements will be done that can be
experienced as more or less stressful.
Blood draw, SC injectiones and the can be experienced as stressful in this
respect.
Orionintie 1A
Espoo FI-02101
FI
Orionintie 1A
Espoo FI-02101
FI
Listed location countries
Age
Inclusion criteria
Healthy male volunteers
18 - 55 years, inclusive
BMI 18 - 30 kilograms/meter2
Weight 55 - 95 kilograms, 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 | EUCTR2014-004460-37-NL |
| CCMO | NL52930.056.15 |