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

NCT03286218 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16853H8H-MC-LAHB
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Recreational Drug Use; Prescription Drug Abuse (Not Dependent)

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores

  The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.

  Each Phase: 24 Hours

Secondary Outcomes (6)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose

• PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose

• PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)

  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

• PD: Maximal Drug Effects (Emax) VAS (Hallucinations)

  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

• PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)

  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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo was administered orally in one of five treatment periods

Drug: Placebo

Alprazolam 2 milligram (mg)

ACTIVE COMPARATOR

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

Drug: Alprazolam

Lasmiditan 100 mg

EXPERIMENTAL

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

Drug: Lasmiditan

Lasmiditan 200 mg

EXPERIMENTAL

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

Drug: Lasmiditan

Lasmiditan 400 mg

EXPERIMENTAL

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

Drug: Lasmiditan

Interventions

Lasmiditan DRUG

Administered orally

Also known as: LY573144

Lasmiditan 100 mg; Lasmiditan 200 mg; Lasmiditan 400 mg

Alprazolam DRUG

Administered orally

Alprazolam 2 milligram (mg)

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Recreational Drug Use; Substance-Related Disorders

Interventions

lasmiditan; Alprazolam

Condition Hierarchy (Ancestors)

Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

(800) 545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 18, 2017
• Study Start: September 15, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: January 10, 2020
• Results First Posted: January 10, 2020

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)