A PHASE I, SINGLE-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE ASCENDING-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GRC 10693 IN HEALTHY MALE SUBJECTS

Completed

Conditions: Chronic neuralgia
10034606

Registration Number: NL-OMON33904

Lead Sponsor: Glenmark Pharmaceuticals SA.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 96

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)).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study has three objectives. Firstly, we will study the safety and<br /><br>tolerability of the drug after the administration of both single and multiple<br /><br>doses of the drug. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondly, we will study the speed at which the drug is absorbed in the body, as<br /><br>well as the degree of elimination of the drug after single and multiple doses.<br /><br><br /><br>Third, in the MAD part in this research also the pain-relieving effect of the<br /><br>researchdrug is examined after administration of pain stimuli on the basis of<br /><br>two pain models.</p><br>