Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects
- Registration Number
- NCT01994668
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Lorazepam Lorazepam -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs). 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 Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) Day 1 Area under the Concentration-Time Curve (AUC) Day1 to Day 4 AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Hachioji-shi, Tokyo, Japan