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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994668
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Lorazepam

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




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs). [ Time Frame: 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 :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 ]
  2. Area under the Concentration-Time Curve (AUC) [ Time Frame: Day1 to Day 4 ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994668


Locations
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Japan
Pfizer Investigational Site
Hachioji-shi, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01994668    
Other Study ID Numbers: B3541001
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014
Keywords provided by Pfizer:
lorazepam
intravenous
pharmacolinetics
healthy
Japanese
Additional relevant MeSH terms:
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Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action