Assessment of Effect of Rapastinel on Driving Performance

Summary

Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the participant's driving performance after single IV doses of rapastinel as compared with single oral doses of alprazolam, a benzodiazepine that demonstrates driving impairment, and placebo in healthy participants.

Conditions

• Driving Performance

Interventions

DRUG

Rapastinel

Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.

DRUG

Alprazolam

Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.

DRUG

Ketamine

Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.

DRUG

Rapastinel Matched Placebo

Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.

DRUG

Alprazolam Matched Placebo

Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.

DRUG

Ketamine Matched Placebo

Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.

Sponsors & Collaborators

• Naurex, Inc, an affiliate of Allergan plc

  lead INDUSTRY

Principal Investigators

• Sheng Fang Su · Allergan

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-05

Primary Completion

2019-03-29

Completion

2019-04-03

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations