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

NCT01071889 | Completed Phase 1 DMC

• 1 other identifier: 0076-10-RMB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Brotizolam

OTHER

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

Drug: Flumazenil; Drug: Placebo

Zolpidem

OTHER

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.

Drug: Flumazenil; Drug: Placebo

Interventions

Flumazenil DRUG

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

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

Brotizolam; Zolpidem

Placebo DRUG

Placebo - only excipients with no API

Brotizolam; Zolpidem

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure.
• 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).
• Body mass index ≥ 18.5 and \< 32 kg/m2.
• 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.
• Subject is in good health as determined by a medical history, physical examination and ECG.
• Negative any use of illicit drug, alcohol (ethanol), stimulants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coeruleus Ltd.: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Interventions

Flumazenil

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 19, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: July 1, 2013
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

IL (1)