Procedural SedationPhase 1NCT04767035
Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine
A Phase 1 study testing midazolam / ketamine sublingual tablet in people with Procedural Sedation, run by Melt Pharmaceuticals at 1 site in United States.
Trial summary
A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- midazolam / ketamine sublingual tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 14 Jan 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Able to understand and voluntarily consent to participation in this study and provides written informed consent before the start of any study-specific procedures.
- 2. Healthy adult male or female at least 55 years of age. 3. Negative test for SARS-CoV2 (COVID-19) 4. Normally active and otherwise judged to be in good health on the basis of medical history and physical examination.
- 5. Has vital signs (measured sitting after a minimum 3 minutes of rest) at Screening within the following ranges: heart rate: 40 to 100 bpm; systolic blood pressure (BP): 90 to145 mmHg; diastolic BP: 50 to 95 mmHg. Out-of-range vital signs may be repeated once.
- 6. Has a body temperature ≤37.7 degrees C 7. Body weight at least 55 kg 8. Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive) 9. 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) 10. 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.
- 11. Is willing and able to remain in the study unit for the entire duration of each confinement period.
Who cannot join
- 1. 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.
- 2. Has a history of glaucoma, asthma, chronic obstructive pulmonary disease, or thyroid disease.
- 3. History and/or family history of congenital long QT syndrome, unexplained syncope, or other additional risks for Torsade de Pointes, or sudden premature death.
- 4. 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.
- 5. Has been in contact with someone within the last month who has tested positive for SARS-CoV-2.
- 6. History of COVID-19. 7. Clinically significant surgery within 4 weeks prior to the administration of the study medication.
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- 8. Has participated in another clinical trial (randomized subjects only) within 30 days before the first dose of study medication.
- 9. 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).
- 10. History or presence of allergic or adverse response to midazolam, ketamine, 11. Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, or vitamins) within 14 days before the first dose of study medication until the EOS without evaluation and approval by the Investigator.
- 12. 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.
- 13. Have had a depot injection or an implant of any drugs 3 months prior to administration of study medication.
- 14. 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 Investigators 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 (for example, amiodarone, fluconazole, ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin) 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.
- 15. 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.
- 16. 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.
- 17. 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. 18. Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Investigator, contraindicates the subjects participation in this study.
- 19. Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- 20. Consumption of beverages or foods that contain alcohol, 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.
- Subject must not consume grapefruit, orange, or apple juice from 7 days 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.
- 21. Engagement in strenuous exercise from 48 hours before the first dose of study medication until the EOS.
- 22. A clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine Under Fasted Conditions in Healthy Volunteers
A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers
Read the detailed description
A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of 2 doses of 3.5mgMELT-100, IV Midazolam, and IV Ketamine 18mg under Fasted Conditions in Healthy Volunteers
- Conditions
- Procedural Sedation
- Being tested
- midazolam / ketamine sublingual tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolam / ketamine sublingual tabletDrug
sublingual tablet
| Study group | Role | What they receive |
|---|---|---|
| MELT-100 3/25 | Active comparator | MELT-100 3mg midazolam / 25 mg ketamine Receives: Drug: midazolam / ketamine sublingual tablet |
| MELT-100 2 x 3/25 | Active comparator | MELT-100 2 doses of 3mg midazolam / 25mg ketamine Receives: Drug: midazolam / ketamine sublingual tablet |
| ketamine IV 18mg | Active comparator | Not described Receives: Drug: midazolam / ketamine sublingual tablet |
| Midazolam IV 3.5mg | Active comparator | Not described Receives: Drug: midazolam / ketamine sublingual tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Concentration
Measured: 24 hours
AUClast
Area under the curve
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 posted23 Feb 2021
- Study start1 Dec 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4-period 4-arm crossover relative bioavailability
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melt Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767035
- Sponsor's protocol ID
- MELT-100-002
- Status last verified
- Feb 2021
- First submitted
- 30 Nov 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 Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine Under Fasted Conditions in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04767035
- Acronym / sponsor ID
- MELT-100-002
- Conditions
- Procedural Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Melt PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 23 Feb 2021 (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.
A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers
Detailed description
A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of 2 doses of 3.5mgMELT-100, IV Midazolam, and IV Ketamine 18mg under Fasted Conditions in Healthy Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4-period 4-arm crossover relative bioavailability
| Arm | Type | Receives |
|---|---|---|
| MELT-100 3/25 | Active comparator | Drug: midazolam / ketamine sublingual tabletMELT-100 3mg midazolam / 25 mg ketamine |
| MELT-100 2 x 3/25 | Active comparator | Drug: midazolam / ketamine sublingual tabletMELT-100 2 doses of 3mg midazolam / 25mg ketamine |
| ketamine IV 18mg | Active comparator | Drug: midazolam / ketamine sublingual tablet |
| Midazolam IV 3.5mg | Active comparator | Drug: midazolam / ketamine sublingual tablet |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Able to understand and voluntarily consent to participation in this study and provides written informed consent before the start of any study-specific procedures.
- 2. Healthy adult male or female at least 55 years of age. 3. Negative test for SARS-CoV2 (COVID-19) 4. Normally active and otherwise judged to be in good health on the basis of medical history and physical examination.
- 5. Has vital signs (measured sitting after a minimum 3 minutes of rest) at Screening within the following ranges: heart rate: 40 to 100 bpm; systolic blood pressure (BP): 90 to145 mmHg; diastolic BP: 50 to 95 mmHg. Out-of-range vital signs may be repeated once.
- 6. Has a body temperature ≤37.7 degrees C 7. Body weight at least 55 kg 8. Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive) 9. 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) 10. 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.
- 11. Is willing and able to remain in the study unit for the entire duration of each confinement period.
Key exclusion criteria (25 listed)
- 1. 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.
- 2. Has a history of glaucoma, asthma, chronic obstructive pulmonary disease, or thyroid disease.
- 3. History and/or family history of congenital long QT syndrome, unexplained syncope, or other additional risks for Torsade de Pointes, or sudden premature death.
- 4. 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.
- 5. Has been in contact with someone within the last month who has tested positive for SARS-CoV-2.
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 / ketamine sublingual tabletsublingual tablet | Drug | MELT-100 2 x 3/25, MELT-100 3/25, Midazolam IV 3.5mg, ketamine IV 18mg |
Primary outcome
Cmax
Time frame: 24 hours
Maximum Concentration
AUClast
Time frame: 24 hours
Area under the curve
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
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 / ketamine sublingual tablet in people with Procedural Sedation, 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 5 inclusion and 25 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?
Cmax (time frame: 24 hours). The study lists 2 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.