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NCT04767035 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Procedural Sedation, sponsored by Melt Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target
1
Study location

NCT04767035: Completed Phase 1 study of Procedural Sedation, sponsored by Melt Pharmaceuticals.

NCT04767035 is a Phase 1 study of Procedural Sedation that has completed, run by Melt Pharmaceuticals. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04767035, a Phase 1 study of Procedural Sedation, has completed, sponsored by Melt Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target
1
Study location

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

Primary Outcome

Maximum Concentration

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
Melt Pharmaceuticals

4 total trials

What the finished NCT04767035 record still lists

NCT04767035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

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.

NCT04767035 reports a single indexed study location in Texas.

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.

What interventions are being tested in trial NCT04767035?

The interventions under investigation include: midazolam / ketamine sublingual tablet (DRUG).

Who is sponsoring clinical trial NCT04767035?

This trial is sponsored by Melt Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Procedural Sedation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04767035's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04767035, the US trial registry maintained by the National Library of Medicine. NCT04767035 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.