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COMPLETED Phase 1

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

NCT04767035 · View on ClinicalTrials.gov ↗

Study 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

Conditions Studied

Interventions

  • DRUG midazolam / ketamine sublingual tablet

Study Locations (1)

Texas

  • Worldwide Clinical Trials — San Antonio

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2020-12-01
Est. Completion 2021-01-14
Phase Phase 1

Sponsor

Melt Pharmaceuticals

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04767035

The ClinicalTrials.gov registry entry for NCT04767035 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Melt Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Procedural Sedation appearing as the primary indexed condition, and to 1 intervention — of which midazolam / ketamine sublingual tablet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04767035 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04767035 about?

NCT04767035 is a clinical study titled "Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine". 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

What is the current status of trial NCT04767035?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2020-12-01. Estimated completion is 2021-01-14.

What conditions does trial NCT04767035 study?

This clinical trial studies the following conditions: Procedural Sedation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04767035?

The interventions under investigation include: midazolam / ketamine sublingual tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04767035?

This trial is sponsored by Melt Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04767035 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial