Safety and effects of SENS-111 (100 mg and 200 mg) in healthy subjects exposed to experimental motio

Phase 1

• Conditions: healthy volunteers (medicine for acute unilateral vertigo); Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2018-000777-80-NL
• Lead Sponsor: Sensorion

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

1.Male
2.Aged =18 years and = 45 years
3.Susceptible to motion sickness defined as MSSQ–short within 10th to 90th percentiles
4.Signed and dated written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.History of acute or chronic vestibular disorder, tinnitus or hearing loss, or inner ear problem
2.Past history of seizures or convulsions
3.Past history of migraine or hyperemesis
4.Subjects with known allergy to meclizine, or to any other histamine antagonist
5.Known severe adverse drug reaction e.g. clinical symptoms of cardiac rhythm disturbances
6.Subjects with known asthma
7.History of alcohol or drug abuse
8.Current participation in another clinical trial
9.Treatment with any investigational agent within 4 weeks prior to randomization or 5 half-lives of the investigational drug (whichever is longer)
10.Subject with known narrow angle glaucoma,
11.Subject with known prostate enlargement or history of urine retention
12.Subject with infection or inflammatory process during screening or at inclusion
13.Positive urine screening for drugs
14.Any abnormality on 12-lead electrocardiogram (ECG), in particular QTc prolongation defined by: QTc >470 ms
15.Clinically significant abnormal blood pressure (>140/90 mmHg) or significant abnormal heart rate (arrhythmia,or tachycardia or bradycardia).
16.Known history of, or concomitant hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological, renal, or dermatological disease, or any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator might interfere with the evaluation of study treatment or warrant exclusion.
17.Abnormal laboratory findings:
a.Creatininemia >1.5 upper limit of normal (ULN))
b.ALAT and/or ASAT > 1.5 x ULN
c.Hemoglobin 10 g/ml and/or
d.Neutrophils <1500/ml and/or
e.Platelets <100 000 /ml
18.Subject is unavailable to complete the study (including all follow-up visits) and comply with study restrictions.
19.Subjects who, in the opinion of the Investigator, have significant medical or psychosocial findings that warrant exclusion. Examples of significant problems include, but are not limited to other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy or significantly increase the risk of SAEs and any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study
20.Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
21.Any treatment within 72 hours prior to inclusion
22.Prior participation in a clinical trial with SENS-111

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective: <br>•To confirm the absence of sedative effects and therefore the maintenance of vigilance with SENS-111 in subjects exposed to a vestibular conflict <br>;Secondary Objective: Secondary Objectives: <br>•To confirm the pharmacodynamic effects of SENS-111 on symptoms experimentally induced by motion.<br>•To assess the safety of SENS-111<br>;Primary end point(s): The primary endpoints reflecting sedation will be assessed by the change of performance over time, compared to baseline, including all test parameters of the<br>•Pepsy psychomotor test battery;<br>•Vigilance & Tracking test.<br>;Timepoint(s) of evaluation of this end point: baseline T=-0:45 before drug intake<br>assessment 1 T=+1:30 after drug intake<br>assessment 2 T=+2:45 after drug intake<br>assessment 3 T=+4:00 after drug intake<br>assessment 4 T=+5:00 after drug intake