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Trial record 1 of 1 for:    NCT01994668
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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

Tracking Information
First Submitted Date  ICMJE November 20, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date March 3, 2014
Study Start Date  ICMJE January 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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 Arms  ICMJE
  • Experimental: Lorazepam
    Intervention: Drug: Lorazepam
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2013)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994668
Other Study ID Numbers  ICMJE B3541001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP