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Safety IssuesPhase 1NCT04113343

Oral Remimazolam With and Without Alcohol in Healthy Female Subjects

A Phase 1 study testing Remimazolam and Alcohol in people with Safety Issues, run by Paion UK Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 21 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Safety Issues
What is being tested?
Remimazolam and Alcohol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited States
Study dates
30 May 2017to 9 Aug 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PRA Health Sciences (PRA) - Early Development Services

    Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions
Safety Issues
Being tested
Remimazolam, Alcohol
Keywords
remimazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemimazolamDrug

    Also called CNS7056

    Remimazolam via oral administration

  • AlcoholOther

    Alcohol

Study groups in NCT04113343
Study groupRoleWhat they receive
Treatment A: remimazolamActive comparatorOral administration of 360 mg remimazolam
Receives: Drug: Remimazolam
Treatment B: remimazolam + 5% v/v alcoholExperimentalOral administration of 360 mg remimazolam and 5% v/v alcohol
Receives: Drug: Remimazolam; Other: Alcohol
Treatment C: remimazolam + 15% v/v alcoholExperimentalOral administration of 360 mg remimazolam + 15% v/v alcohol
Receives: Drug: Remimazolam; Other: Alcohol
Treatment D: remimazolam + 40% v/v alcoholExperimentalOral administration of 360 mg remimazolam + 40% v/v alcohol
Receives: Drug: Remimazolam; Other: Alcohol
Treatment E: placebo + 40% v/v alcoholPlacebo comparatorOral administration of Placebo + 40% v/v alcohol
Receives: Other: Alcohol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paired Associates Learning (PAL) Test

    PAL Test was conducted using the software CANTAB (Cambridge Cognition)

    Measured: Predose to 4 hours postdose

  2. Modified Observer Assessment of Alertness/Sedation (MOAA/S)

    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).

    Measured: Predose to 4 hours postdose

  3. Alertness/Drowsiness Visual Analog Scale (VAS)

    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

    Measured: Predose to 4 hours postdose

  4. Reaction Time Test (RTI)

    RTI was conducted using the software CANTAB (Cambridge Cognition).

    Measured: Predose to 4 hours postdose

  5. Maximum observed plasma concentration (Cmax)

    Measured: Predose to 8 hours postdose

  6. Time to Maximum observed plasma concentration (Tmax)

    Measured: Predose to 8 hours postdose

  7. Area under the plasma concentration-time curve (AUC) from zero to the last measurable concentration

    Measured: Predose to 8 hours postdose

  8. Terminal elimination half-life (T1/2)

    Measured: Predose to 8 hours postdose

  9. Apparent oral clearance (CL/F)

    Measured: Predose to 8 hours postdose

  10. Apparent volume of distribution at terminal Phase (Vz/F)

    Measured: Predose to 8 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2019
  2. Study start30 May 2017
  3. Primary completion9 Aug 2017
  4. Study completion9 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04113343
Sponsor's protocol ID
CNS7056-020
Status last verified
Oct 2019
First submitted
27 Sep 2019
Last updated
2 Oct 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pesic M, Stohr T, Ossig J, Borkett K, Donsbach M, Dao VA, Webster L, Schippers F. Remimazolam Has Low Oral Bioavailability and No Potential for Misuse in Drug-Facilitated Sexual Assaults, with or Without Alcohol: Results from Two Randomised Clinical Trials. Drugs R D. 2020 Sep;20(3):267-277. doi: 10.1007/s40268-020-00317-0.

    PubMed 32757149

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Remimazolam and Alcohol in people with Safety Issues, run by Paion UK Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paired Associates Learning (PAL) Test (time frame: Predose to 4 hours postdose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04113343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.

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