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

NCT04485702 | Completed Phase 1 FDA Drug

• 1 other identifier: MELT-100-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  24 hours

• Area under the plasma concentration versus time curve (AUC)

  24 hours

• Time to peak plasma concentration (Tmax)

  24 hours

Study Arms (3)

MELT-100

ACTIVE COMPARATOR

3mg midazolam and 25mg ketamine sublingual tablet

Drug: MELT-100

IV midazolam

ACTIVE COMPARATOR

2mg Intravenous midazolam

Drug: Midazolam injection

IV ketamine

ACTIVE COMPARATOR

6mg Intravenous ketamine

Drug: Ketamine Injectable Product

Interventions

Midazolam injection DRUG

2mg IV

IV midazolam

Ketamine Injectable Product DRUG

6mg IV

IV ketamine

MELT-100 DRUG

midazolam 3mg and ketamine 25mg SL tablet

MELT-100

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Melt Pharmaceuticals: lead
• Worldwide Clinical Trials: collaborator

Study Sites (1)

WWCT

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Cynthia Zamora, MD

  Worldwide Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: randomization
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Single-Dose, 6-Sequence, 3-Period, Crossover

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 24, 2020
• Study Start: July 20, 2020
• Primary Completion: August 29, 2020
• Study Completion: August 29, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)