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

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

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg lorazepam intravenous administration in healthy Japanese adult subjects.
Condition	Healthy
Intervention	Drug: Lorazepam Drug: Placebo
Phase	Phase 1
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT01994668
First Received	November 20, 2013
Last Updated	February 28, 2014
Last verified	February 2014

Tracking Information[ + expand ][ + ]

First Received Date	November 20, 2013
Last Updated Date	February 28, 2014
Start Date	January 2014
Estimated Primary Completion Date	February 2014
Current Primary Outcome Measures	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs). [Time Frame: Day 1 to Day 4] [Designated as safety issue: Yes]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.
Current Secondary Outcome Measures	Maximum Observed Plasma Concentration (Cmax) [Time Frame: Day 1] [Designated as safety issue: No] Area under the Concentration-Time Curve (AUC) [Time Frame: Day1 to Day 4] [Designated as safety issue: No]AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Descriptive Information[ + expand ][ + ]

Brief Title	Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects
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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Condition	Healthy
Intervention	Drug: Lorazepam A single intravenous administration of 2 mg lorazepam over 1 minute Drug: Placebo A single intravenous administration of 0.9% saline over 1 minute
Study Arm (s)	Experimental: Lorazepam Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	8
Estimated Completion Date	February 2014
Estimated Primary Completion Date	February 2014
Eligibility Criteria	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.
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Japan

Administrative Information[ + expand ][ + ]

NCT Number	NCT01994668
Other Study ID Numbers	B3541001
Has Data Monitoring Committee	No
Information Provided By	Pfizer
Study Sponsor	Pfizer
Collaborators	Not Provided
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
Verification Date	February 2014

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