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

Healthy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071889
• Other study ID #: 0076-10-RMB
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 17, 2010
• Last updated: January 29, 2015
• Start date: May 2010
• Est. completion date: July 2013

Study information

• Verified date: January 2015
• Source: Coeruleus Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Flumazenil
Flumazenil- 0.4 mg per 100 µl in a sublingual spray administration
• Placebo
Placebo - only excipients with no API

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Coeruleus Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No