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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03286218
Recruitment Status : Completed
First Posted : September 18, 2017
Results First Posted : January 10, 2020
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Recreational Drug Use Prescription Drug Abuse (Not Dependent) Drug: Lasmiditan Drug: Alprazolam Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Subject- and Investigator-Blind, Placebo and Active-Controlled Study to Assess the Abuse Potential of Lasmiditan
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 20, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo was administered orally in one of five treatment periods
Drug: Placebo
Administered orally

Active Comparator: Alprazolam 2 milligram (mg)
2 mg of alprazolam was administered orally in one of five treatment periods
Drug: Alprazolam
Administered orally

Experimental: Lasmiditan 100 mg
100 mg of lasmiditan was administered orally in one of five treatment periods
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Experimental: Lasmiditan 200 mg
200 mg of lasmiditan was administered orally in one of five treatment periods
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Experimental: Lasmiditan 400 mg
400 mg of lasmiditan was administered orally in one of five treatment periods
Drug: Lasmiditan
Administered orally
Other Name: LY573144




Primary Outcome Measures :
  1. Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores [ Time Frame: Each Phase: 24 Hours ]
    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.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose ]
    Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan

  2. PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞]) [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose ]
    PK defined as the area under the curve of lasmiditan from zero to infinity (AUC[0-∞])

  3. PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS) [ Time Frame: 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 ]
    Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. Scales include: Overall drug liking (overall, my liking for this drug is) and ranges from 0 definitely not to 100 definitely so. Take Drug Again (I would take this drug again) and ranges from 0 definitely not to 100 definitely so. Good effects (I can feel good drug effects) and ranges from 0 definitely not to 100 definitely so. Bad effects (I can feel bad drug effects) and ranges from 0 definitely not to 100 definitely so. High (I am feeling) and ranges from 0 not at all high to 100 extremely high. Emax is derived as the maximum score across all postdose time points for each participant. Least Square (LS) Mean is calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.

  4. PD: Maximal Drug Effects (Emax) VAS (Hallucinations) [ Time Frame: 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 ]
    Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The hallucinations scale is presented meaning (I am hallucinating) and ranges from 0 not at all to 100 extremely. Emax is derived as the maximum score across all postdose time points for each participant. Median and interquartile range are reported for each treatment group.

  5. PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS) [ Time Frame: 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 ]
    Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The scales included: Alertness/Drowsiness (I am feeling) ranges from 0 very drowsy to 100 very alert. Agitation/Relaxation (my mood is) and ranges from 0 very relaxed to 100 very agitated. Emin is derived across all postdose time points for each participant. LS Mean was calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.

  6. PD: Mean Scores on Drug Similarity VAS Measures [ Time Frame: Each Phase: 24 Hours Post Dose ]
    Participants marked a point on a 100-mm horizontal line that best represented their response to the given question. The endpoints of each electronic scale were marked with descriptive anchors on a scale from 0 to 100 (Fraser et al. 1961; Bond and Lader 1974; Bigelow 1991; Shram et al. 2010). In the "How similar" questions, ranges from 0 to 100 and a score of 0 indicates definitely not similar, and a score of 100 indicates definitely similar.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286218


Locations
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United States, Kansas
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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 Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] September 5, 2017
Statistical Analysis Plan  [PDF] September 11, 2017

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03286218    
Other Study ID Numbers: 16853
H8H-MC-LAHB ( Other Identifier: Eli Lilly and Company )
First Posted: September 18, 2017    Key Record Dates
Results First Posted: January 10, 2020
Last Update Posted: January 10, 2020
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action