NCT04113343

Oral Remimazolam With and Without Alcohol in Healthy Female Subjects

A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Paion UK Ltd. · Industry
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects

Detailed description

Evaluating the potential for additive or synergistic effects of alcohol when coadministered with remimazolam. Female subjects were selected because they represent the population at greatest risk for victimization in drug-facilitated sexual assault. In addition, females have a slower ethanol metabolism, therefore, the effects of remimazolam, if coadministered with alcohol, may last longer. Hence, this population represents the worst-case scenario in evaluating the risk of remimazolam misuse in drug-facilitated assault.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	Remimazolam	Remimazolam via oral administration
OTHER	Alcohol	Alcohol

Timeline

• Start date: 2017-05-30
• Primary completion: 2017-08-09
• Completion: 2017-08-09
• First posted: 2019-10-02
• Last updated: 2019-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study