Healthy VolunteersPhase 1NCT04485702
Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine
A Phase 1 study testing Midazolam injection, Ketamine Injectable Product and MELT-100 in people with Healthy Volunteers, run by Melt Pharmaceuticals at 1 site in United States.
Trial summary
Comparative Bioavailability study testing MELT-100 (midazolam and ketamine sublingual tablet) and IV midazolam or ketamine in healthy volunteers Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Midazolam injection, Ketamine Injectable Product and MELT-100
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2020to 29 Aug 2020
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A subject must satisfy all of the following criteria to be eligible for study participation:
- Able to understand and voluntarily consent to participation in this study, and provides written informed consent before the start of any study-specific procedures.
- Healthy adult male or female ≥55 years of age.
- Normally active and otherwise judged to be in good health on the basis of medical history and physical examination.
- Has vital signs (measured sitting after a minimum 3 minutes rest) at Screening within the following ranges: heart rate: 40-100 bpm; systolic blood pressure (BP): 90-145 mmHg; diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once.
- Has a body temperature ≤37.7 degrees C
Show all 12Show fewer
- Body weight ≥55 kg
- Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive)
- Female subjects are eligible only if the following applies:
- Surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy), or postmenopausal (confirmed with serum FSH at Screening)
- Male subjects must either be surgically sterile (vasectomy at least 3 months prior to first dose) or agree to use an acceptable method of birth control (see Section 4.4) from Screening through EOS.
- Is willing and able to remain in the study unit for the entire duration of each confinement period.
Who cannot join
- Subjects will be excluded from study participation for any of the following:
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, ophthalmologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Has a history of glaucoma, asthma, chronic obstructive pulmonary disease, or thyroid disease.
- Clinically significant illnesses within 4 weeks of the administration of study medication (including flu, flu-like symptoms, diarrhea, vomiting, fever, sore throat) or acute illness at the time of either the pre-study medical evaluation or dosing.
- Has been in contact with someone within the last month who has tested positive for SARS-CoV-2.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Show all 32Show fewer
- Has participated in another clinical trial (randomized subjects only) within 30 days before the first dose of study medication.
- An active malignancy of any type, or has been diagnosed with cancer within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin).
- History or presence of allergic or adverse response to midazolam, ketamine, Versed, KETALAR, or any ingredients of MELT-100 or related drugs.
- Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, or vitamins) within 7 days before the first dose of study medication until the EOS without evaluation and approval by the Investigator.
- Use of any prescription medication, except statin drugs or hormonal replacement therapy, from 14 days before the first dose of study medication until the EOS without evaluation and approval by the Investigator.
- Have had a depot injection or an implant of any drugs 3 months prior to administration of study medication.
- Has been treated with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) within 30 days before the first dose of study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results.
- Specifically, the use of any drugs known to inhibit CYP2C9 and CYP3A4 enzymes (examples include amiodarone, fluconazole, ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit or orange or apple juice) or any drugs that are highly protein-bound (for example, warfarin, cyclosporine, amphotericin B) within 30 days prior to the first dose of study medication, and that in the Investigator's judgment may impact subject safety or the validity of the study results.
- Blood or plasma donation within 30 days before the first dose of study medication until the EOS. It is recommended that blood/plasma donations not be made for at least 30 days after the EOS.
- Has any prior history of substance abuse or treatment (including alcohol).
- History of significant alcohol abuse within 6 months of Screening or any indication of the regular use of more than 2 units of alcohol per day (1 unit = 50 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- History of use of marijuana within 3 months of Screening or drugs such as cocaine, phencyclidine (PCP), within 1 year of Screening.
- Smoking or use of tobacco- or nicotine-containing products within 60 days before the first dose of study medication until the EOS Note: Nonsmokers are preferred for this study.
- Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Investigator, contraindicates the subject's participation in this study.
- Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- Consumption of beverages or foods that contain alcohol, grapefruit, poppy seeds, broccoli, Brussels sprouts, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 48 hours before the first dose of study medication until the EOS. Subjects will be instructed not to consume any of the above products; however, allowance for an isolated single incidental consumption may be evaluated and approved by the study Investigator based on the potential for interaction with the study drug.
- Engagement in strenuous exercise from 48 hours before the first dose of study medication until the EOS.
- A clinically significant abnormal finding on the physical examination, medical history, electrocardiogram (ECG), or clinical laboratory results at Screening.
- Note: Laboratory test values above or below the normal range does not necessarily indicate that the value is "clinically significant." The determination should be made at the discretion of the Investigator with consultation, when necessary, with the Sponsor.
- Presence of active infection, mucositis, cold sores, apthous ulcers, vesicles, viral lesions, local irritation/inflammation, or periodontal disease of the oral cavity. In addition, evidence of piercings of the tongue or anywhere in the oral cavity, history of oral cavity piercings, or history of significant dental disease or braces or oral hardware.
- Clinically significant ECG abnormalities at Screening.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ˃1.25 times the upper limit of normal at Screening or Check-in for Period 1.
- Is a female with a positive pregnancy test result.
- Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine.
- Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at Screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- Has poor venous access during blood sampling at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Phase 1, Randomized, Single-Dose, 6-Sequences, 3-Period, Crossover Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual Tablet) and Intravenous Midazolam or Ketamine in Healthy Volunteers
Comparative Bioavailability study testing MELT-100 (midazolam and ketamine sublingual tablet) and IV midazolam or ketamine in healthy volunteers
- Conditions
- Healthy Volunteers
- Being tested
- Midazolam injection, Ketamine Injectable Product, MELT-100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam injectionDrug
2mg IV
Ketamine Injectable ProductDrug
6mg IV
MELT-100Drug
midazolam 3mg and ketamine 25mg SL tablet
| Study group | Role | What they receive |
|---|---|---|
| MELT-100 | Active comparator | 3mg midazolam and 25mg ketamine sublingual tablet Receives: Drug: MELT-100 |
| IV midazolam | Active comparator | 2mg Intravenous midazolam Receives: Drug: Midazolam injection |
| IV ketamine | Active comparator | 6mg Intravenous ketamine Receives: Drug: Ketamine Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Measured: 24 hours
Area under the plasma concentration versus time curve (AUC)
Measured: 24 hours
Time to peak plasma concentration (Tmax)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start20 Jul 2020
- Primary completion29 Aug 2020
- Study completion29 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomized, Single-Dose, 6-Sequence, 3-Period, Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melt Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Cynthia Zamora, MD, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485702
- Sponsor's protocol ID
- MELT-100-001
- Status last verified
- Feb 2021
- First submitted
- 17 Jul 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase 1, Randomized, Single-Dose, 6-Sequences, 3-Period, Crossover Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual Tablet) and Intravenous Midazolam or Ketamine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04485702
- Acronym / sponsor ID
- MELT-100-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Melt PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 29 Aug 2020 (actual)
- Study completion
- 29 Aug 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative Bioavailability study testing MELT-100 (midazolam and ketamine sublingual tablet) and IV midazolam or ketamine in healthy volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized, Single-Dose, 6-Sequence, 3-Period, Crossover
| Arm | Type | Receives |
|---|---|---|
| MELT-100 | Active comparator | Drug: MELT-1003mg midazolam and 25mg ketamine sublingual tablet |
| IV midazolam | Active comparator | Drug: Midazolam injection2mg Intravenous midazolam |
| IV ketamine | Active comparator | Drug: Ketamine Injectable Product6mg Intravenous ketamine |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A subject must satisfy all of the following criteria to be eligible for study participation:
- Surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy), or postmenopausal (confirmed with serum FSH at Screening)
Key exclusion criteria (32 listed)
- Subjects will be excluded from study participation for any of the following:
- Specifically, the use of any drugs known to inhibit CYP2C9 and CYP3A4 enzymes (examples include amiodarone, fluconazole, ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit or orange or apple juice) or any drugs that are highly protein-bound (for example, warfarin, cyclosporine, amphotericin B) within 30 days prior to the first dose of study medication, and that in the Investigator's judgment may impact subject safety or the validity of the study results.
- Note: Laboratory test values above or below the normal range does not necessarily indicate that the value is "clinically significant." The determination should be made at the discretion of the Investigator with consultation, when necessary, with the Sponsor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam injection2mg IV | Drug | IV midazolam |
| Ketamine Injectable Product6mg IV | Drug | IV ketamine |
| MELT-100midazolam 3mg and ketamine 25mg SL tablet | Drug | MELT-100 |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 24 hours
Area under the plasma concentration versus time curve (AUC)
Time frame: 24 hours
Time to peak plasma concentration (Tmax)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Zamora, MD principal investigator
Worldwide Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam injection, Ketamine Injectable Product and MELT-100 in people with Healthy Volunteers, run by Melt Pharmaceuticals 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 12 inclusion and 32 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 23 Feb 2021. 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?
Peak Plasma Concentration (Cmax) (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2021.