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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2014

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Lorazepam
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 20 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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