Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2020-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparative Bioavailability study testing MELT-100 (midazolam and ketamine sublingual tablet) and IV midazolam or ketamine in healthy volunteers

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine

NCT04767035

Procedural Sedation

COMPLETED PHASE1

A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR)

NCT05133518

Cataract

COMPLETED PHASE2

To Evaluate the Effect of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers

NCT02140268

Healthy Volunteers

COMPLETED PHASE1

Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of CTX 4430 and Midazolam

NCT02233244

Healthy

COMPLETED PHASE1

A Randomized, Double-Masked, Controlled, Single Site Investigator Initiated, Exploratory Study of the Midazolam/Ketamine Melt vs Ketamine Melt Alone vs Midazolam Melt Alone in Subjects Undergoing Intraocular Surgery.

NCT04725747

Anesthesia

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, Single-Dose, 6-Sequence, 3-Period, Crossover

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

randomization

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MELT-100

3mg midazolam and 25mg ketamine sublingual tablet

Group Type ACTIVE_COMPARATOR

MELT-100

Intervention Type DRUG

midazolam 3mg and ketamine 25mg SL tablet

IV midazolam

2mg Intravenous midazolam

Group Type ACTIVE_COMPARATOR

Midazolam injection

Intervention Type DRUG

2mg IV

IV ketamine

6mg Intravenous ketamine

Group Type ACTIVE_COMPARATOR

Ketamine Injectable Product

Intervention Type DRUG

6mg IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Midazolam injection

2mg IV

Intervention Type DRUG

Ketamine Injectable Product

6mg IV

Intervention Type DRUG

MELT-100

midazolam 3mg and ketamine 25mg SL tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A subject must satisfy all of the following criteria to be eligible for study participation:

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 ≥55 years of age.
3. Normally active and otherwise judged to be in good health on the basis of medical history and physical examination.
4. 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.
5. Has a body temperature ≤37.7 degrees C
6. Body weight ≥55 kg
7. Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive)
8. 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)
9. 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.
10. Is willing and able to remain in the study unit for the entire duration of each confinement period.

Exclusion Criteria

* Subjects will be excluded from study participation for any of the following:

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. 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.
4. Has been in contact with someone within the last month who has tested positive for SARS-CoV-2.
5. Clinically significant surgery within 4 weeks prior to the administration of the study medication.
6. Has participated in another clinical trial (randomized subjects only) within 30 days before the first dose of study medication.
7. 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).
8. History or presence of allergic or adverse response to midazolam, ketamine, Versed, KETALAR, or any ingredients of MELT-100 or related drugs.
9. 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.
10. 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.
11. Have had a depot injection or an implant of any drugs 3 months prior to administration of study medication.
12. 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.
13. 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.
14. Has any prior history of substance abuse or treatment (including alcohol).

1. 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%).
2. History of use of marijuana within 3 months of Screening or drugs such as cocaine, phencyclidine (PCP), within 1 year of Screening.
15. 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.
16. Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Investigator, contraindicates the subject's participation in this study.
17. Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
18. 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.
19. Engagement in strenuous exercise from 48 hours before the first dose of study medication until the EOS.
20. 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.
21. 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.
22. Clinically significant ECG abnormalities at Screening.
23. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ˃1.25 times the upper limit of normal at Screening or Check-in for Period 1.
24. Is a female with a positive pregnancy test result.
25. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine.
26. 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.
27. Has poor venous access during blood sampling at Screening.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes