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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01994668

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Lorazepam Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lorazepam	Drug: Lorazepam A single intravenous administration of 2 mg lorazepam over 1 minute
Placebo Comparator: Placebo	Drug: Placebo A single intravenous administration of 0.9% saline over 1 minute

Arm

Intervention/Treatment

Experimental: Lorazepam

Drug: Lorazepam

A single intravenous administration of 2 mg lorazepam over 1 minute

Placebo Comparator: Placebo

Drug: Placebo

A single intravenous administration of 0.9% saline over 1 minute

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.