A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users

• Status: Completed
• Trial end date: 2017-11-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the abuse potential of study drug lasmiditan.

Lasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any active drug) to determine the potential for drug abuse. The dosages will be in tablet form and will be taken orally (by mouth).

This study will last about 55 days, including screening. Screening will occur within 28 days prior to qualification phase.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Alprazolam; Lasmiditan

Criteria

Inclusion Criteria:

• Are overtly healthy males or females, as determined by medical history and physical examination.

• Have a body mass index (BMI) of 18 to 32 kilograms per meter squared (kg/m²) inclusive, at the time of screening.

• Must be recreational drug user and agree not to consume any recreational drugs during the study.

Exclusion Criteria:

• Have known allergies to lasmiditan, alprazolam, related compounds, or any components of the formulation, or a history of significant atopy.

• Are currently seeking or participating in treatment for addiction or substance-related disorders, or have recovered from substance abuse disorder.

• Are currently taking excluded prescription or over-the-counter (OTC) medications.

• Have a history of significant sleep disorder, including sleep apnea or narcolepsy.

• Have a history of orthostatic hypotension, vertigo, syncope, or presyncope.

• Have a history of brain injury, including a history of concussions.