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

Phase 1CompletedNCT01994668

Pfizer8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

LorazepamDRUG

A single intravenous administration of 2 mg lorazepam over 1 minute

PlaceboDRUG

A single intravenous administration of 0.9% saline over 1 minute

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Hachioji-shi, Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).

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.

Time frame: Day 1 to Day 4

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1

Area under the Concentration-Time Curve (AUC)

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Time frame: Day1 to Day 4

Data from ClinicalTrials.gov

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