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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lorazepam; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01994668

B3541001

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups, including a placebo group

Lorazepam

Experimental group

Treatment:

Drug: Lorazepam

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo