A randomized, cross-over, placebo controlled, and meclizine calibrated study to assess the safety and pharmacodynamic effects of SENS-111 (100 mg and 200 mg) single dose in healthy subjects exposed to experimental motio

Phase 2

Completed

• Conditions: bij gezonde proefpersonen; mate van misselijkheid en behoud van alertheid na inname medicatie; Nauseau & vigiliance

• Registration Number: NL-OMON46445
• Lead Sponsor: Sensorion

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-11-23
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

1. Male
2. Aged *18 years and * 45 years
3. Susceptible to motion sickness defined as MSSQ*short within 10th to 95th percentiles
4. Signed and dated written informed consent.

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 smoker
9. Current participation in another clinical trial
10. Treatment with any investigational agent within 4 weeks prior to randomization or 5 half-lives of the investigational drug (whichever is longer)
11. Subject with known narrow angle glaucoma,
12. Subject with known prostate enlargement or history of urine retention
13. Subject with infection or inflammatory process during screening or at inclusion
14. Positive urine screening for drugs
15. Any abnormality on 12-lead electrocardiogram (ECG), in particular QTc prolongation defined by: QTc >470 ms
16. Clinically significant abnormal blood pressure (>140/90 mmHg) or significant abnormal heart rate (arrhythmia, or tachycardia or bradycardia).
17. 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.
18. 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
19. Subject is unavailable to complete the study (including all follow-up visits) and comply with study restrictions.
20. 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
21. 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.
22. Any treatment within 72 hours prior to inclusion
23. Prior participation in a clinical trial with SENS-111

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints reflecting sedation will be assessed by the change of<br /><br>performance over time, compared to baseline, including all test parameters of<br /><br>the<br /><br>* Vigilance & Tracking test<br /><br>* Pepsy psychomotor test battery;</p><br>