Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults

Double-blind, Randomized, Placebo and Active Controlled Study to Assess the Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults(Zolpidem or Brotizolam)

Sponsors

Lead Sponsor: Coeruleus Ltd.

Source Coeruleus Ltd.
Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of treatment with sublingual (s/l) Flumazenil in healthy volunteers as reversing the effect of the sleep/hypnotic drugs. This study is designed to collect short-term safety and tolerability data. In addition, the psychomotor/ cognitive and behavioral effects of Flumazenil will be assessed to monitor the degree and the duration of action in a single use of Flumazenil.

Overall Status Completed
Start Date May 2010
Completion Date July 2013
Primary Completion Date August 2012
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs 6 months
Secondary Outcome
Measure Time Frame
Efficacy of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs 6 months
Enrollment 10
Condition
Intervention

Intervention Type: Drug

Intervention Name: Flumazenil

Description: Flumazenil- 0.4 mg per 100 µl in a sublingual spray administration

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo - only excipients with no API

Eligibility

Criteria:

Inclusion Criteria: 1. The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure. 2. Male or female aged 18-65 at screening. Women of childbearing potential must have a negative pregnancy test at the screening visit and use a reliable method of contraception during the entire study duration (e.g. Contraceptive pill; Intra-uterine device; Contraceptive injection (prolonged-release gestagen); Subdermal implantation;Vaginal ring or Transdermal patch). 3. Body mass index ≥ 18.5 and < 32 kg/m2. 4. Normal sleep habits, i.e. usual self-reported total sleep time > 6 h; usual self-reported time to fall asleep < 30 min; usual bedtime between 10:30 pm and 01:00 am. 5. Subject is in good health as determined by a medical history, physical examination and ECG. 6. Negative any use of illicit drug, alcohol (ethanol), stimulants. Exclusion Criteria: 1. Any use of medications within 1 month prior to screening visit, except for contraceptive pills. 2. Any sleep associated complains. 3. Previous exposure to Benzodiazepines and/or non-Benzodiazepine hypnotic drugs within 3 months prior to study initiation. 4. History of Epilepsy and or anti-epileptic drugs. 5. Excessive caffeine consumption (≥ 500 mg per day). 6. Pregnancy or breast feeding. 7. Night shift workers within 1 month prior to the screening visit. 8. Clinically relevant ECG abnormalities. 9. History of alcohol or drug abuse within 3 years prior to the screening visit. 10. Cognitive Behavioral Therapy (CBT) started within 1 month prior to the screening visit. 11. Known hypersensitivity to drugs of the same class as the study treatment, or any excipients of the drug formulation. 12. Treatment with another investigational drug within 1 month prior to the screening visit. 13. History of severe head injury.

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Rambam Medical Center
Location Countries

Israel

Verification Date

January 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Brotizolam

Type: Other

Description: Treatment response will be evaluated for each treatment arm. Good Response (GR) - is considered as an improvement of 30% in efficacy parameters of Flumazenil treatment in comparison to placebo

Label: Zolpidem

Type: Other

Description: Treatment response will be evaluated for each treatment arm. Good Response (GR) - is considered as an improvement of 30% in efficacy parameters of Flumazenil treatment in comparison to placebo.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov