Back to resultsA Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users
Primary Purpose
Recreational Drug Use, Prescription Drug Abuse (Not Dependent)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lasmiditan
Alprazolam
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Recreational Drug Use
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.
Sites / Locations
- Vince & Associates Clinical Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Alprazolam 2 milligram (mg)
Lasmiditan 100 mg
Lasmiditan 200 mg
Lasmiditan 400 mg
Arm Description
Placebo was administered orally in one of five treatment periods
2 mg of alprazolam was administered orally in one of five treatment periods
100 mg of lasmiditan was administered orally in one of five treatment periods
200 mg of lasmiditan was administered orally in one of five treatment periods
400 mg of lasmiditan was administered orally in one of five treatment periods
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan
PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])
PK defined as the area under the curve of lasmiditan from zero to infinity (AUC[0-∞])
PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)
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.
PD: Maximal Drug Effects (Emax) VAS (Hallucinations)
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.
PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)
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.
PD: Mean Scores on Drug Similarity VAS Measures
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.
Full Information
NCT ID
NCT03286218
First Posted
September 15, 2017
Last Updated
December 20, 2019
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT03286218
Brief Title
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
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recreational Drug Use, Prescription Drug Abuse (Not Dependent)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was administered orally in one of five treatment periods
Arm Title
Alprazolam 2 milligram (mg)
Arm Type
Active Comparator
Arm Description
2 mg of alprazolam was administered orally in one of five treatment periods
Arm Title
Lasmiditan 100 mg
Arm Type
Experimental
Arm Description
100 mg of lasmiditan was administered orally in one of five treatment periods
Arm Title
Lasmiditan 200 mg
Arm Type
Experimental
Arm Description
200 mg of lasmiditan was administered orally in one of five treatment periods
Arm Title
Lasmiditan 400 mg
Arm Type
Experimental
Arm Description
400 mg of lasmiditan was administered orally in one of five treatment periods
Intervention Type
Drug
Intervention Name(s)
Lasmiditan
Other Intervention Name(s)
LY573144
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Alprazolam
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores
Description
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.
Time Frame
Each Phase: 24 Hours
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Description
Pharmacokinetics (PK) defined as the 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
Title
PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])
Description
PK defined as the 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
Title
PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)
Description
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.
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
Title
PD: Maximal Drug Effects (Emax) VAS (Hallucinations)
Description
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.
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
Title
PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)
Description
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.
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
Title
PD: Mean Scores on Drug Similarity VAS Measures
Description
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.
Time Frame
Each Phase: 24 Hours Post Dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Vince & Associates Clinical Research, Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users
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