Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects

A Phase 1, Randomized Single-blind (Subject-blind), Placebo Controlled Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01994668

Enrollment

Registered

2013-11-26

Start date

2014-01-31

Completion date

2014-02-28

Last updated

2014-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

lorazepam, intravenous, pharmacolinetics, healthy, Japanese

Brief summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg lorazepam intravenous administration in healthy Japanese adult subjects.

Interventions

DRUGLorazepam

A single intravenous administration of 2 mg lorazepam over 1 minute

DRUGPlacebo

A single intravenous administration of 0.9% saline over 1 minute

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Japanese male and/or female subjects of non-childbearing potential. * Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg.

Exclusion criteria

* History of sensitivity to lorazepam or other benzodiazepines. * Evidence or history of acute narrow-angle glaucoma or sleep apnea syndrome. * Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).	Day 1 to Day 4	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Secondary

Measure	Time frame	Description
Maximum Observed Plasma Concentration (Cmax)	Day 1	—
Area under the Concentration-Time Curve (AUC)	Day1 to Day 4	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026