Clinical trial NCT03286218: A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users
Official title: A Randomized, Subject- and Investigator-Blind, Placebo and Active-Controlled Study to Assess the Abuse Potential of Lasmiditan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recreational Drug Use
Prescription Drug Abuse (Not Dependent)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores
timeFrame: Each Phase: 24 Hours
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose
measure: PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose
measure: PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)
timeFrame: Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
measure: PD: Maximal Drug Effects (Emax) VAS (Hallucinations)
timeFrame: Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
measure: PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)
timeFrame: Each Phase:Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
measure: PD: Mean Scores on Drug Similarity VAS Measures
timeFrame: Each Phase: 24 Hours Post Dose
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research, Inc.
state: Kansas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: