The study has three objectives. Firstly, we will study the safety and tolerability of the drug after the administration of both single and multiple doses of the drug. Secondly, we will study the speed at which the drug is absorbed in the body, as…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study has three objectives. Firstly, we will study the safety and
tolerability of the drug after the administration of both single and multiple
doses of the drug.
Secondary outcome
Secondly, we will study the speed at which the drug is absorbed in the body, as
well as the degree of elimination of the drug after single and multiple doses.
Third, in the MAD part in this research also the pain-relieving effect of the
researchdrug is examined after administration of pain stimuli on the basis of
two pain models.
Background summary
GRC 10693 is a new drug that can stimulate the cannaboid-2-receptor. The
cannaboid-2-receptor has an action in transmitting pain signals in patients
with chronic neuralgia. Stimulation of the cannaboid-2-receptor could limit the
transmission of these pain signals. GRC 10693 would be a pain killer for
patients with post herpatic neuralgia or neuralgia due to diabetes.
Study objective
The study has three objectives. Firstly, we will study the safety and
tolerability of the drug after the administration of both single and multiple
doses of the drug. Secondly, we will study the speed at which the drug is
absorbed in the body, as well as the degree of elimination of the drug after
single and multiple doses. Third, in the MAD part in this research also the
pain-relieving effect of the researchdrug is examined after administration of
pain stimuli on the basis of two pain models.
Study design
SAD: (At least) Seven groups of eight healthy male volunteers will participate
in this study. The study will include a medical examination, one admission
period of three days, visits on days 4 and day 5, and finally a follow-up.
MAD: Four groups of eight healthy male volunteers will participate in this
study. The study will include a medical examination, one admission period of
eighteen days, three short visits and finally a follow-up.
Study burden and risks
The risks for the volunteers participating in this trial are related to the
possible side effects of the investigational product. Next, the inconvenience
for the volunteer depends on the duration of the admission period,
venapunctures and inserting the cannula. All volunteers will be closely
monitored by experienced physicians and other staff.
Chemin de la Combeta 5
2300 La Chaux-de-Fonds
Switzerland
Chemin de la Combeta 5
2300 La Chaux-de-Fonds
Switzerland
Listed location countries
Age
Inclusion criteria
1. Subjects must be Caucasian males, 18-45 years of age, inclusive;
2. Subjects must voluntarily sign a written informed consent agreement;
3. Subjects must be in good health, based upon the results of medical history, physical examination, electrocardiogram (ECG) and laboratory profiles of both blood and urine.;For the first cohort of the MAD study, in addition to the inclusion criteria as given above in D4, the following applies and/or overrides the corresponding exclusion criterion for the SAD study
1. Subjects who were administered a single dose of GRC 10963 in the SAD stage of the study may be enrolled.
2. Subjects who have turned 46 years of age since their participation in the SAD study may be enrolled.;Recruitment criteria of subjects for subsequent cohorts in the MAD stage may be equivalent to criteria of cohorts in SAD stage (after review of the results of the previous SAD and MAD cohort(s)).
Exclusion criteria
1. Subjects who smoke (subjects will have to be non-smokers for at least 6 months preceding screening);
2. Subjects with active presence or history of alcoholism or drug addiction;
3. Subject who had an operation in the within 3 months prior to the (first) dosing day;
4. Subjects who have used over-the-counter medication (including homeopathic medicines and vitamins), within 96 hours (h) prior to the dosing day, with the exception of paracetamol, which is allowed at the discretion of the PI;
5. Subjects who have used prescription medication within 2 weeks prior to the first dosing day;
6. Subjects who have participated in an investigational drug study within 3 months prior to the dosing day;
7. Subjects who have lost or donated >350 ml of blood within 12 weeks prior to the (first) dosing day;
8. Subjects who test positive for hepatitis B, C or HIV;
9. Subjects who are considered unsuitable to participate in the study for any reason in the opinion of the PI.;For the first cohort of the MAD study, next to the exclusion criteria as given above in D5, the following applies and/or overrides the corresponding exclusion criterion for the SAD study:
1. Subjects who have participated in an investigational drug study except the SAD study of GRC 10963 within 3 months prior to the dosing day;
2. Subjects who have participated in the SAD stage of the study and whose exposure to GRC 10693 in terms of Cmax¬ and/or AUC0 * was more than two times the median value for the dose group, and/or whose terminal elimination half-life exceeded 52 hours.
3. Subjects who were administered a single dose of GRC 10963 in the SAD stage of the study may be enrolled with a Body Mass Index (BMI) <18.0 or >30.0 kg/m2;Exclusion criteria of subjects for subsequent cohorts in the MAD stage may be equivalent to criteria of cohorts in SAD stage (after review of the results of the previous SAD and MAD cohort(s)).
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-004239-39-NL |
| CCMO | NL23902.040.08 |