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BioavailabilityPhase 1NCT04113564

Absolute Oral Bioavailability of Remimazolam

A Phase 1 study testing Remimazolam in people with Bioavailability, 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 randomized, open-label, single-dose, 2-way crossover study to compare the relative bioavailability of orally administered remimazolam to an intravenous formulation in healthy volunteers Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Bioavailability
What is being tested?
Remimazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
3 Nov 2015to 20 Nov 2015
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Willing to participate in the study, willing to give written informed consent prior to the initiation of any protocol-specific procedures, and willing to comply with the study restrictions.
  • Had to be able to speak, read, and understand English sufficiently to allow completion of all study assessments.
  • Gender : males and/or females
  • Age : 18 - 55 years, inclusive
  • Body mass index (BMI) : 18.0 - 32.0 kg/m2
  • Weight : ≥50 kg
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  • Healthy status was 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 ECG, hematology, clinical chemistry, serology, and urinalysis.
  • 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 study 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.
  • Females of childbearing potential and males and their female partner(s) of childbearing potential had to agree to use 2 forms of contraception, 1 of which had to be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception were condom and diaphragm. Acceptable non-barrier forms of contraception for this study were an intrauterine device (IUD) and/or spermicide.
  • For females: a negative pregnancy test at Screening and Day -1.
  • Postmenopausal females: defined as 12 months with no menses prior to Screening and a serum follicle stimulating hormone (FSH) >40 IU/L at Screening.
  • All non-regular medication (including over-the-counter [OTC] medication, health supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to admission to the clinical research center. An exception was made for paracetamol (acetaminophen), which was allowed up to admission to the clinical research center.

Who cannot join

  • Women who were pregnant or lactating.
  • Males with female partners who were pregnant or lactating.
  • Use of any investigational drug or device within 30 days of the first dose of study 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 derivates or flumazenil, or a medical condition such that these agents were contraindicated.
  • The use of tobacco products within 60 days prior to the first drug administration.
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  • Routine or chronic use of more than 3 grams of acetaminophen daily.
  • Strenuous activity, sunbathing and contact sports within 48 hours (2 days) prior to admission to the clinical facility and for the duration of the study.
  • History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical research center or planned donation before 30 days had elapsed since intake of study drug.
  • Plasma or platelet donation within 7 days of dosing and throughout the entire study.
  • History of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption was prohibited from 48 hours prior to admission to the clinical facility and throughout the entire study until discharge.
  • 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 results for drugs of abuse, including cotinine, in the urine at Screening or Day -1.
  • Positive results for alcohol abuse, as determined by alcohol breath test, at Screening or Day -1.
  • Inability to be venipunctured or 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 study.
  • Any major surgery within 4 weeks of study 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 (EDS)

    Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: A Randomized, Open-label, Single-dose, 2-way Crossover Study to Compare the Relative Bioavailability of Orally Administered Remimazolam to an Intravenous Formulation in Healthy Volunteers

A randomized, open-label, single-dose, 2-way crossover study to compare the relative bioavailability of orally administered remimazolam to an intravenous formulation in healthy volunteers

Conditions
Bioavailability
Being tested
Remimazolam

What participants receive

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

  • RemimazolamDrug

    Also called CNS7056

Study groups in NCT04113564
Study groupRoleWhat they receive
IV remimazolamExperimentalIV remimazolam administration of 0.025 mg/kg body weight
Receives: Drug: Remimazolam
Oral remimazolamExperimentalOral remimazolam Administration of 0.14 mg/kg Body weight
Receives: Drug: Remimazolam

What is being measured

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

  1. Absolute oral bioavailability of remimazolam

    Single-dose bioavailability of an oral formulation of remimazolam relative to an IV formulation of remimazolam in healthy male and female subjects

    Measured: Day 1 (pre-dode) to Day 3

Secondary outcomes (7)

  1. Maximum Plasma concentration (Cmax)

    Maximum observed plasma concentration

    Measured: Day 1 (pre-dode) to Day 3

  2. Time to Maximum Plasma concentration (Tmax)

    Time to attain maximum observed plasma concentration

    Measured: Day 1 (pre-dode) to Day 3

  3. Area under the plasma concentration-time curve (AUC0-t)

    Area under the plasma concentration-time curve from time 0 up to the time of the last measurable concentration

    Measured: Day 1 (pre-dode) to Day 3

  4. Elimination half-life (T1/2)

    Terminal elimination half-life

    Measured: Day 1 (pre-dode) to Day 3

  5. Clearance (CL/F)

    Apparent oral clearance

    Measured: Day 1 (pre-dode) to Day 3

  6. Volume of Distribution (Vz/F)

    Apparent volume of distribution at terminal phase

    Measured: Day 1 (pre-dode) to Day 3

  7. Incidences of Treatment-emergent adverse events

    Incidences of Treatment-emergent adverse events

    Measured: Day 1 (pre-dode) to Day 3

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 start3 Nov 2015
  3. Primary completion20 Nov 2015
  4. Study completion20 Nov 2015

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04113564
Sponsor's protocol ID
CNS7056-016
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 in people with Bioavailability, 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 17 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. 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?

Absolute oral bioavailability of remimazolam (time frame: Day 1 (pre-dode) to Day 3). 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 NCT04113564, 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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