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

NCT ID: NCT01071889

Last Updated: 2015-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Brotizolam

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

Group Type: OTHER

Flumazenil

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo - only excipients with no API

Zolpidem

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.

Group Type: OTHER

Flumazenil

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo - only excipients with no API

Interventions

Flumazenil

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

Intervention Type: DRUG

Placebo

Placebo - only excipients with no API

Intervention Type: DRUG

Other Intervention Names

Romzicon,; Anexate®,; BRN 4763661,; Flumazenilo (Spanish),; Flumazenilum (Latin),; Flumazepil; Lanexat®,; Mazicon®,; Ro 151788,; Ro-15-1788,; Romazicon®,; UNII-40P7XK9392

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coeruleus Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rambam Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

0076-10-RMB

Identifier Type: -

Identifier Source: org_study_id