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

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

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

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.