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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAHA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it by comparing the results of healthy elderly participants to those of healthy young participants. The tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected.
This study will last up to approximately 19 days, not including screening. This study requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four days/three nights. Participants will return for a follow-up seven days after last dose of study drug. Screening is required within 28 days prior to Day 1.
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 |
|---|---|---|---|
| 200 mg Lasmiditan (Group 1 Elderly) | Experimental | 200 milligrams (mg) lasmiditan on Day 1 of 1 of 2 dosing periods. |
|
| Placebo (Group 1 Elderly) | Placebo Comparator | Placebo on Day 1 of 1 of 2 dosing periods. |
|
| 200 mg Lasmiditan (Group 2 Young) | Experimental | 200 mg lasmiditan on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Maximum Observed Drug Concentration (Cmax) of Lasmiditan. | Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan | Area under the concentration versus time curve from zero to infinity | Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours |
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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 | ||
| Covance Evansville |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Group 1 Elderly | Placebo on day 1 of period 1 200 mg of lasmiditan on Day 1 of period 2. |
| FG001 | Sequence 2: Group 1 Elderly | 200 mg of lasmiditan on Day 1 of period 1. Placebo on Day 1 of period 2. |
| FG002 | 200 mg Lasmiditan (Group 2 Young) | 200 mg of lasmiditan on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Washout Period |
| |||||||||||||
| Period 2 |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Elderly | Placebo on Day 1 of 1 of 2 dosing periods or 200 milligrams (mg) lasmiditan on Day 1 of 1 of 2 dosing periods. |
| BG001 | 200 mg Lasmiditan (Group 2 Young) | 200 mg of lasmiditan on Day 1. |
| 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 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Maximum Observed Drug Concentration (Cmax) of Lasmiditan. | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms Per Millilitre (ng/mL) | Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours |
|
Up to 10 Days
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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 | Placebo (Group 1 Elderly) | Placebo on Day 1 of 1 of 2 dosing periods. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photopsia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2017 | May 21, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 5, 2017 | Dec 9, 2019 | Prot_002.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
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2 Groups: Group 1 - Double-blind Randomized 2-Period Crossover, Group 2 - Open-label single dose
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| Placebo | Drug | Oral administration |
|
| Evansville |
| Indiana |
| 47710 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Units | Counts |
|---|---|
| Participants |
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|
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| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan | Area under the concentration versus time curve from zero to infinity | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour per Millilitre (ng.h/mL) | Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours |
|
|
|
|
| 18 |
| 0 |
| 18 |
| 3 |
| 18 |
| EG001 | 200 mg Lasmiditan (Group 1 Elderly) | 200 mg lasmiditan on Day 1 of 1 of 2 dosing periods. | 0 | 18 | 0 | 18 | 8 | 18 |
| EG002 | 200 mg Lasmiditan (Group 2 Young) | 200 mg of lasmiditan on Day 1. | 0 | 17 | 0 | 17 | 8 | 17 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Sensation of foreign body | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Visual field defect | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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