NCT04485702 is a Phase 1 clinical trial of Midazolam injection in Healthy Volunteers, sponsored by Melt Pharmaceuticals.

Who is sponsoring NCT04485702?

NCT04485702 is sponsored by Melt Pharmaceuticals.

What drugs are being tested in NCT04485702?

Interventions in NCT04485702: Midazolam injection, Ketamine Injectable Product, MELT-100.

What condition does NCT04485702 study?

NCT04485702 studies Healthy Volunteers.

Is NCT04485702 still recruiting?

NCT04485702 is currently completed. Last updated 23 February 2021.

Last reviewed 2021-02-23 · How we verify

NCT04485702

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 23 February 2021

What this trial tests

Phase 1 trial testing Midazolam injection in Healthy Volunteers in 17 participants. Completed in 29 August 2020.

Timeline

20 July 2020

Primary endpoint
29 August 2020

29 August 2020

Quick facts

Lead sponsor	Melt Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	17
Start date	20 July 2020
Primary completion	29 August 2020
Estimated completion	29 August 2020
Sites	1 location across United States

Drugs / interventions tested

Midazolam injection — full drug profile →
Ketamine Injectable Product — full drug profile →
MELT-100 — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Melt Pharmaceuticals — full company profile →

Who can join

55 and older, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Midazolam injection

Trials testing the same drug.

NCT03223220 — Quelling of Excitotoxicity in Acute Stroke With Ketamine · Phase 2, PHASE3 · not yet recruiting
NCT05528718 — SMILE Trial - Imaging Sub-Study · completed
NCT05558449 — Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia · Phase 4 · completed
NCT04220125 — Preoperative Ketamine and Perioperative Depression · Phase 4 · withdrawn
NCT05046184 — Elucidating the Neurocircuitry of Irritability With High-Field Neuroimaging to Identify Novel Therapeutic Targets · Phase 2 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Melt Pharmaceuticals trials

Trials by the same sponsor.

NCT05133518 — A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Part · Phase 2 · completed
NCT04767035 — Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04485702 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Melt Pharmaceuticals
Last refreshed: 23 February 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04485702.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing