- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04113343
Oral Remimazolam With and Without Alcohol in Healthy Female Subjects
October 1, 2019 updated by: Paion UK Ltd.
A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects
A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects
Study Overview
Detailed Description
Evaluating the potential for additive or synergistic effects of alcohol when coadministered with remimazolam.
Female subjects were selected because they represent the population at greatest risk for victimization in drug-facilitated sexual assault.
In addition, females have a slower ethanol metabolism, therefore, the effects of remimazolam, if coadministered with alcohol, may last longer.
Hence, this population represents the worst-case scenario in evaluating the risk of remimazolam misuse in drug-facilitated assault.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84106
- PRA Health Sciences (PRA) - Early Development Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Willing to participate in the trial, give written informed consent prior to the initiation of any protocol-specific procedures, and comply with the trial restrictions.
- Able to speak, read, and understand English sufficiently to allow completion of all Trial assessments.
- Gender : female
- Age : 21 to 45 years, inclusive
- Weight : ≥ 50 kg
- Body mass index (BMI) : 18.0 to 33.0 kg/m2, inclusive
- Healthy status, defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiograms (ECG), hematology, blood chemistry, serology, and urinalysis.
- Current alcohol user classified as a moderate drinker, defined as drinking > 2 drinks/week and ≤ 14 drinks/week (1 drink equals approximately 12 oz/350 mL of beer, 5 oz/150 mL of wine, or 1.5 oz/45 mL of spirits).6
- Ability and willingness to abstain from alcohol, caffeine, and xanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to admission to the clinical facility on Day -1 until trial discharge.
- All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator.
- A negative pregnancy test at Screening and Day -1.
- Females of childbearing potential must have agreed to use 2 forms of contraception, one of which must have been a barrier method, during the trial and for 90 days after the last drug administration. Acceptable barrier forms of contraception were condom and diaphragm. Acceptable nonbarrier forms of contraception for this trial were oral contraceptives, injectable hormone contraceptives, implantable birth control, intrauterine devices, and/or spermicide. Injectable hormonal contraception was allowable as a nonbarrier method.
- Females who were not of childbearing potential, including postmenopausal females (defined as 12 months with no menses prior to Screening and a serum follicle-stimulating hormone [FSH] > 40 IU/L at Screening) or females who were surgically sterilized.
Exclusion Criteria:
- Females who were pregnant or lactating.
- Known intolerance towards alcohol (symptoms could include nausea, flushed face, vomiting, or hypotension upon drinking) or known alcohol dehydrogenase deficiency.
- of Asian descent (one or both parents) due to potential for genetic polymorphism related to aldehyde dehydrogenase deficiency.
- History of alcohol abuse or drug addiction (except nicotine or caffeine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text Revision (DSM-V-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
- History of relevant food allergies.
- Use of any investigational drug or device within 30 days of the first dose of Trial medication.
- Any disease which, in the opinion of the Investigator, posed an unacceptable risk to the subjects.
- Known allergy, hypersensitivity, or prior intolerance to benzodiazepine derivatives or flumazenil, or a medical condition such that these agents were contraindicated.
- Use of tobacco products within 60 days prior to the first drug administration.
- Routine or chronic use of more than 3 grams of acetaminophen daily.
- History of donation or loss of more than 450 mL of blood or blood products within 60 days prior to dosing in the clinical research center or planned donation before 30 days had elapsed since intake of trial drug in the current trial.
- Positive screening test for hepatitis B surface antigen (HBsAg), anti-hepatitis C Virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
- Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at Screening and admission to the clinical research center.
- Average intake of > 14 drinks of alcohol per week (1 drink equals approximately 12 oz/350 mL of beer, 5 oz/150 mL of wine, or 1.5 oz/45 mL of spirits).
- Required concomitant treatment with any prescription or non-prescription medications (with the exception of hormonal contraceptives, hormone replacement, and acetaminophen) or natural health products (herbal remedies), or respiratory depressants, or could not safely discontinue these medications at least 7 days prior to receiving trial drug.
- Inability to be venipunctured or to tolerate venous access, as determined by the Investigator or designee.
- History of clinically significant, recent/current, and nonremote suicidal ideations or suicide attempts that, in the opinion of the Investigator, posed an unacceptable risk to the subject for participating in the trial.
- Any major surgery within 4 weeks of trial drug administration. NOTE: Any parameter/test could be repeated at the Investigator's discretion during Screening and/or on Day -1.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Treatment A: remimazolam
Oral administration of 360 mg remimazolam
|
Remimazolam via oral administration
Other Names:
|
EXPERIMENTAL: Treatment B: remimazolam + 5% v/v alcohol
Oral administration of 360 mg remimazolam and 5% v/v alcohol
|
Remimazolam via oral administration
Other Names:
Alcohol
|
EXPERIMENTAL: Treatment C: remimazolam + 15% v/v alcohol
Oral administration of 360 mg remimazolam + 15% v/v alcohol
|
Remimazolam via oral administration
Other Names:
Alcohol
|
EXPERIMENTAL: Treatment D: remimazolam + 40% v/v alcohol
Oral administration of 360 mg remimazolam + 40% v/v alcohol
|
Remimazolam via oral administration
Other Names:
Alcohol
|
PLACEBO_COMPARATOR: Treatment E: placebo + 40% v/v alcohol
Oral administration of Placebo + 40% v/v alcohol
|
Alcohol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Paired Associates Learning (PAL) Test
Time Frame: Predose to 4 hours postdose
|
PAL Test was conducted using the software CANTAB (Cambridge Cognition)
|
Predose to 4 hours postdose
|
Modified Observer Assessment of Alertness/Sedation (MOAA/S)
Time Frame: Predose to 4 hours postdose
|
The MOAA/S scale is a validated, 6-point rating scale that involves an observer rating subjects' responsiveness to stimuli of increasing intensity (5 = alert, 0 = sedated).
|
Predose to 4 hours postdose
|
Alertness/Drowsiness Visual Analog Scale (VAS)
Time Frame: Predose to 4 hours postdose
|
The Alertness/Drowsiness VAS was administered as a 100-point bipolar scale, with 50 being the neutral point, as follows:0: Very drowsy, 50: Neither drowsy nor alert, 100: Very alert
|
Predose to 4 hours postdose
|
Reaction Time Test (RTI)
Time Frame: Predose to 4 hours postdose
|
RTI was conducted using the software CANTAB (Cambridge Cognition).
|
Predose to 4 hours postdose
|
Maximum observed plasma concentration (Cmax)
Time Frame: Predose to 8 hours postdose
|
Predose to 8 hours postdose
|
|
Time to Maximum observed plasma concentration (Tmax)
Time Frame: Predose to 8 hours postdose
|
Predose to 8 hours postdose
|
|
Area under the plasma concentration-time curve (AUC) from zero to the last measurable concentration
Time Frame: Predose to 8 hours postdose
|
Predose to 8 hours postdose
|
|
Terminal elimination half-life (T1/2)
Time Frame: Predose to 8 hours postdose
|
Predose to 8 hours postdose
|
|
Apparent oral clearance (CL/F)
Time Frame: Predose to 8 hours postdose
|
Predose to 8 hours postdose
|
|
Apparent volume of distribution at terminal Phase (Vz/F)
Time Frame: Predose to 8 hours postdose
|
Predose to 8 hours postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ahad Sabet, MD, PRA Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 30, 2017
Primary Completion (ACTUAL)
August 9, 2017
Study Completion (ACTUAL)
August 9, 2017
Study Registration Dates
First Submitted
September 27, 2019
First Submitted That Met QC Criteria
October 1, 2019
First Posted (ACTUAL)
October 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 2, 2019
Last Update Submitted That Met QC Criteria
October 1, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CNS7056-020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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