Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults
- Registration Number
- NCT01071889
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure.
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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).
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Body mass index ≥ 18.5 and < 32 kg/m2.
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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.
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Subject is in good health as determined by a medical history, physical examination and ECG.
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Negative any use of illicit drug, alcohol (ethanol), stimulants.
- Any use of medications within 1 month prior to screening visit, except for contraceptive pills.
- Any sleep associated complains.
- Previous exposure to Benzodiazepines and/or non-Benzodiazepine hypnotic drugs within 3 months prior to study initiation.
- History of Epilepsy and or anti-epileptic drugs.
- Excessive caffeine consumption (≥ 500 mg per day).
- Pregnancy or breast feeding.
- Night shift workers within 1 month prior to the screening visit.
- Clinically relevant ECG abnormalities.
- History of alcohol or drug abuse within 3 years prior to the screening visit.
- Cognitive Behavioral Therapy (CBT) started within 1 month prior to the screening visit.
- Known hypersensitivity to drugs of the same class as the study treatment, or any excipients of the drug formulation.
- Treatment with another investigational drug within 1 month prior to the screening visit.
- History of severe head injury.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Brotizolam Placebo 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 Zolpidem Flumazenil 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. Zolpidem Placebo 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. Brotizolam Flumazenil 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
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
Rambam Medical Center
🇮🇱Haifa, Israel
Rambam Medical Center🇮🇱Haifa, Israel