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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994668
• Other study ID #: B3541001
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2013
• Last updated: February 28, 2014
• Start date: January 2014
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lorazepam
A single intravenous administration of 2 mg lorazepam over 1 minute
• Placebo
A single intravenous administration of 0.9% saline over 1 minute

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Hachioji-shi	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 to Day 4	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax)		Day 1	No
Secondary	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.	Day1 to Day 4	No

External Links

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