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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAIG | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to evaluate the effect of lasmiditan on blood pressure, as well as 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 in healthy elderly participants. The tolerability of the study drug will also be evaluated. Information about any side effects that may occur will also be collected. This study will take about 11 days, not including screening. Screening is required within 28 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasmiditan 200 mg (milligrams) | Experimental | Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 (milliliter) mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. |
|
| Lasmiditan 100 mg | Experimental | Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. |
|
| Placebo | Placebo Comparator | Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Change From Baseline in Peak Hourly Mean Values of Systolic Blood Pressure (SBP) | Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using linear mixed effects model adjusting for baseline, treatment, treatment sequence, period, treatment by time point interaction, and a random effect of participant. | Baseline through 24 hours after each administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdose |
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan |
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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 Clinical Research Inc | Daytona Beach | Florida | 32117 | United States | ||
| Covance Clinical Research Inc |
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Crossover study with three study periods, each participant received single oral doses of Lasmiditan 200 milligrams (mg), Lasmiditan 100 mg and Placebo tablets as per the dosing sequence in each period. The washout period between dosing in consecutive study periods was at least 48 hours.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg and Period 3: Placebo |
| FG001 | Sequence 2 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Lasmiditan 100 mg, Period 2: Placebo and Period 3: Lasmiditan 200 mg |
| FG002 | Sequence 3 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Placebo, Period 2: Lasmiditan 200 mg and Period 3: Lasmiditan 100 mg |
| FG003 | Sequence 4 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Placebo, Period 2: Lasmiditan 100 mg and Period 3: Lasmiditan 200 mg |
| FG004 | Sequence 5 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Lasmiditan 200 mg, Period 2: Placebo and Period 3: Lasmiditan 100 mg |
| FG005 | Sequence 6 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg and Period 3: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg and Period 3: Placebo |
| BG001 | Sequence 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pharmacodynamics: Change From Baseline in Peak Hourly Mean Values of Systolic Blood Pressure (SBP) | Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using linear mixed effects model adjusting for baseline, treatment, treatment sequence, period, treatment by time point interaction, and a random effect of participant. | All randomized participants who received at least one dose of study drug and have data for SBP | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline through 24 hours after each administration of study drug |
|
Up To 12 days
All randomized participants who received at least one 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 | Lasmiditan 200 mg | Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2017 | Feb 27, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2018 | Feb 27, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
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| Placebo | Drug | Administered orally. |
|
PK: Area under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of Lasmiditan. |
| Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdose |
| Madison |
| Wisconsin |
| 53704 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Placebo and Period 3: Lasmiditan 200 mg
| BG002 | Sequence 3 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Placebo, Period 2: Lasmiditan 200 mg and Period 3: Lasmiditan 100 mg |
| BG003 | Sequence 4 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Placebo, Period 2: Lasmiditan 100 mg and Period 3: Lasmiditan 200 mg |
| BG004 | Sequence 5 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Lasmiditan 200 mg, Period 2: Placebo and Period 3: Lasmiditan 100 mg |
| BG005 | Sequence 6 | Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule. Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg and Period 3: Placebo |
| BG006 | Total | Total of all reporting groups |
| Participants |
| No |
|
| 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 |
|
| OG000 |
| Lasmiditan 200 mg |
Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 (milliliters) mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. |
| OG001 | Lasmiditan 100 mg | Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. |
| OG002 | Placebo | Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan. | All randomized participants who received at least one dose of study drug and have evaluable pharmacokinetics (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdose |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan | PK: Area under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of Lasmiditan. | All randomized participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdose |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 15 |
| 36 |
| EG001 | Lasmiditan 100 mg | Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. | 0 | 35 | 0 | 35 | 6 | 35 |
| EG002 | Placebo | Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position. | 0 | 35 | 0 | 35 | 0 | 35 |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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Details of the Study and its results shall not be publicized in any form without prior consent of the Sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.