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

Lilly

Status and phase: Completed; Phase 1

Conditions: Prescription Drug Abuse (Not Dependent); Recreational Drug Use

Treatments: Drug: Placebo; Drug: Alprazolam; Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03286218

H8H-MC-LAHB (Other Identifier)

16853

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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96 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo was administered orally in one of five treatment periods

Treatment:

Drug: Placebo

Alprazolam 2 milligram (mg)

Active Comparator group

Description:

2 mg of alprazolam was administered orally in one of five treatment periods

Treatment:

Drug: Alprazolam

Lasmiditan 100 mg

Experimental group

Description:

100 mg of lasmiditan was administered orally in one of five treatment periods

Treatment:

Drug: Lasmiditan

Lasmiditan 200 mg

Experimental group

Description:

200 mg of lasmiditan was administered orally in one of five treatment periods

Treatment:

Drug: Lasmiditan

Lasmiditan 400 mg

Experimental group

Description:

400 mg of lasmiditan was administered orally in one of five treatment periods

Treatment:

Drug: Lasmiditan