NCT01994668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 3, 2014

Status Verified

February 1, 2014

Enrollment Period

1 month

First QC Date

November 20, 2013

Last Update Submit

February 28, 2014

Conditions

Healthy

Keywords

lorazepamintravenouspharmacolineticshealthyJapanese

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).

    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.

    Day 1 to Day 4

Secondary Outcomes (2)

  • Maximum Observed Plasma Concentration (Cmax)

    Day 1

  • Area under the Concentration-Time Curve (AUC)

    Day1 to Day 4

Study Arms (2)

Lorazepam

EXPERIMENTAL
Drug: Lorazepam

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LorazepamDRUG

A single intravenous administration of 2 mg lorazepam over 1 minute

Lorazepam
PlaceboDRUG

A single intravenous administration of 0.9% saline over 1 minute

Placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Hachioji-shi, Tokyo, Japan

Location

Related Links

MeSH Terms

Interventions

Lorazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

January 1, 2014

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 3, 2014

Record last verified: 2014-02

Locations

JP(1)