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Completed

NCT Number: NCT01994668

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

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

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Hachioji-shi, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lorazepam

Drug

A single intravenous administration of 2 mg lorazepam over 1 minute

Placebo

Drug

A single intravenous administration of 0.9% saline over 1 minute

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2013
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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