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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAHE | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it.
When drugs are taken together, one or all of the drugs used in combination may be affected. This study will also evaluate the concentrations in the blood of a probe drug cocktail taken alone and in combination with lasmiditan. Information about any side effects that may occur will also be collected.
The study has two parts. Participants will only enroll in one part. This study will last about 25 days for group 1 and 22 days for group 2, not including screening. Screening is required within 28 days prior to the start of the study.
This study is for research purposes only and is not intended to treat any medical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probe Drug Cocktail (Cohort 1a) | Experimental | Probe Drug Cocktail administered orally on Day -3. |
|
| 200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1) | Experimental | 200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. |
|
| Placebo+Probe Drug Cocktail (Cohort 1b) | Placebo Comparator | Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. |
|
| 400 mg Lasmiditan (Cohort 2a) | Experimental | 400 mg lasmiditan administered orally for 7 days. |
|
| Placebo (Cohort 2b) | Experimental | Placebo administered orally for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probe Drug Cocktail | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module. | Baseline through 14 days after last administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1 | PK: Cmax of lasmiditan | Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Daytona Beach | Daytona Beach | Florida | 32117 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1a (Placebo+Probe Drug Cocktail) | Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7. |
| FG001 | Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7. |
| FG002 | Cohort 2a (Placebo) | Placebo administered daily PO, Days 1-7. |
| FG003 | Cohort 2b (400 mg Lasmiditan) | Daily,oral (PO), 400 mg lasmiditan Days 1-7 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1a (Placebo+Probe Drug Cocktail) | Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. |
| BG001 | Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through 14 days after last administration of study drug |
|
Baseline through 28 days
All participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Probe Drug Cocktail (Cohort 1) | Probe drug cocktail administered on Day 13 and Day 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nodal rhythm | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheif Medical Officer | Eli Lilly and Company | 800-545-5979 | Clinicaltrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2017 | Jun 13, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2017 | Dec 20, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
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| Lasmiditan | Drug | Administered orally |
|
|
| Placebo | Drug | Administered orally |
|
PK: Cmax of lasmiditan Day 7 |
| Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose |
| Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1 | PK: AUCtau of lasmiditan | Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose |
| Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7 | PK AUCtau of lasmiditan | Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose |
| Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort. | PreDose Day 7 and Day 21 |
| Physician Withdrawal Checklist (PWC)Total Score | Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | Day 7 and Day 21 at anytime |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1 | Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan. | Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7 | Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan. | Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam | PK: Cmax of midazolam. | Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose, |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7 | PK of midazolam. | Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose |
| Adverse Event |
|
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
| BG002 | Cohort 2a (Placebo) | Placebo administered daily PO, Days 1-7. |
| BG003 | Cohort 2b (400 mg Lasmiditan) | Daily,oral (PO), 400 mg lasmiditan Days 1-7 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter squared |
|
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) |
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7. |
| OG002 | Cohort 2a (Placebo) | Placebo administered daily PO, Days 1-7. |
| OG003 | Cohort 2b (400 mg Lasmiditan) | Daily,oral (PO), 400 mg lasmiditan Days 1-7 |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1 | PK: Cmax of lasmiditan | All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7 | PK: Cmax of lasmiditan Day 7 | All participants who received at least 1 dose of lasmiditan on Day 7 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1 | PK: AUCtau of lasmiditan | All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms times hour per milliLiter | Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7 | PK AUCtau of lasmiditan | All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms time hours per milliLiter | Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose |
|
|
|
| Secondary | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort. | All participants who received at least 1 dose of study drug and completed the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | PreDose Day 7 and Day 21 |
|
|
|
|
| Secondary | Physician Withdrawal Checklist (PWC)Total Score | Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. | All participants who received at least 1 dose of study drug and had completed the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 21 at anytime |
|
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1 | Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan. | All participant who received at least 1 dose of lasmiditan and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/mL | Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7 | Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan. | All participants who received at least one dose of lasmiditan and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam | PK: Cmax of midazolam. | All randomized participant who received midazolam on Day -3 and had evaluable PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliLiter | Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose, |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7 | PK of midazolam. | All randomized participant who received midazolam on Day 7 and had evaluable PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 200 mg Lasmiditan QD (Cohort 1) | Daily,oral (PO), 200 mg lasmiditan Days 1-6 | 0 | 28 | 0 | 28 | 13 | 28 |
| EG002 | 200 mg Lasmiditan QD + Probe Drug Cocktail (Cohort 1) | Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7. | 0 | 27 | 0 | 27 | 4 | 27 |
| EG003 | Placebo QD (Cohort 1) | Placebo administered daily PO, Days 1-7 | 0 | 12 | 0 | 12 | 5 | 12 |
| EG004 | Placebo QD + Probe Drug Cocktail (Cohort 1) | Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7 | 0 | 11 | 0 | 11 | 1 | 11 |
| EG005 | 400 mg Lasmiditan QD (Cohort 2) | Daily,oral (PO), 400 mg lasmiditan Days 1-7 | 0 | 15 | 0 | 15 | 5 | 15 |
| EG006 | Placebo QD (Cohort 2) | Placebo administered daily PO, Days 1-7 | 0 | 15 | 0 | 15 | 4 | 15 |
| Palpitations | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Wrong technique in product usage process | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
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|
| Day 21 |
|
|
| Mean Difference (Final Values) |
| 0.071 |
| 2-Sided |
| 95 |
| -0.081 |
| 0.224 |
| Superiority |
| Day 21 | Mean Difference (Final Values) | 0.000 | 2-Sided | 95 | 0.000 | 0.000 | Superiority |
| Day 21 | Mean Difference (Final Values) | 0.000 | 2-Sided | 95 | 0.000 | 0.000 | Superiority |
|
| Day 21 |
|
|
| Mean Difference (Final Values) |
| 0.071 |
| 2-Sided |
| 95 |
| -0.081 |
| 0.224 |
| Superiority |
| Day 21 | Mean Difference (Final Values) | 0.071 | 2-Sided | 95 | -0.151 | 0.294 | Superiority |
| Day 21 | Mean Difference (Final Values) | 0.000 | 2-Sided | 95 | 0.000 | 0.000 | Superiority |