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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAHU | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess whether taking lasmiditan and sumatriptan together will have any additional effects on heart rate and blood pressure compared to taking lasmiditan and sumatriptan individually. This study will also 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 when these two drugs are taken together.
This study will last about 21 days, not including the screening. Participants will spend 16 days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is required within 28 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasmiditan + Sumatriptan (A) | Experimental | Single oral dose of 200 milligram (mg) lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet in one of four treatment periods. |
|
| Lasmiditan + Placebo (B) | Experimental | Single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet in one of four treatment periods. |
|
| Sumatriptan + Placebo (C) | Active Comparator | Single oral dose of 100 mg sumatriptan tablet and single oral dose of placebo tablet in one of four treatment periods. |
|
| Placebo + Placebo (D) | Placebo Comparator | Oral doses of placebo tablets in one of four treatment periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) | 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) mean peak changes from baseline were calculated using a linear mixed-effects model with baseline, treatment, period, and sequence as fixed effects and participant as a random effect. | Baseline (Day 1), Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan and Sumatriptan | PK: Cmax of Lasmiditan and Sumatriptan was evaluated. | Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 , 24 ,36 and 48 hours(h) postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose |
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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 |
Crossover study with four periods. Participants were randomized to one of four treatment (Treatment A: 200 milligram (mg) lasmiditan + 100mg sumatriptan, Treatment B: 200mg lasmiditan + placebo, Treatment C: 100mg sumatriptan + placebo, Treatment D: placebo + placebo) period sequences. There was a washout of at least 4 days between each dosing day.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence. Period 1: 200 mg Lasmiditan + 100 mg sumatriptan, Period 2: 200 mg Lasmiditan + placebo Period 3: 100 mg Sumatriptan + placebo Period 4: Placebo + placebo |
| FG001 | Sequence 2 | Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence. Period 1: 200 mg Lasmiditan + placebo Period 2: 100 mg Sumatriptan + placebo Period 3: Placebo + placebo Period 4: 200 mg Lasmiditan + 100 mg sumatriptan |
| FG002 | Sequence 3 | Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence. Period 1: 100 mg Sumatriptan + placebo Period 2: Placebo + placebo Period 3: 200 mg Lasmiditan + 100 mg sumatriptan Period 4: 200 mg Lasmiditan + placebo |
| FG003 | Sequence 4 | Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo + placebo Period 2: 200 mg Lasmiditan + 100 mg sumatriptan Period 3: 200 mg Lasmiditan + placebo Period 4: 100 mg Sumatriptan + placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period Title: Period 4 |
|
All enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants received single oral dose of 200 mg lasmiditan, 100 mg sumatriptan, 200 mg lasmiditan + 100 mg sumatriptan or placebo tablets on Day 1 of each treatment period according to their assigned treatment sequence. |
| 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 | Pharmacodynamics (PD): Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) | 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) mean peak changes from baseline were calculated using a linear mixed-effects model with baseline, treatment, period, and sequence as fixed effects and participant as a random effect. | All enrolled participants who received at least one dose of study drug with evaluable blood pressure data. | Posted | Least Squares Mean | 90% Confidence Interval | Millimeters of mercury (mmHg) | Baseline (Day 1), Day 2 |
|
Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
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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 | 200 mg Lasmiditan + 100 mg Sumatriptan (A) | Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet on day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 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 | Oct 20, 2017 | Mar 4, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2017 | Mar 4, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Sumatriptan | Drug | Administered orally |
|
| Placebo for Lasmiditan | Drug | Administered orally |
|
| Placebo for Sumatriptan | Drug | Administered orally |
|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0 ∞]) of Lasmiditan and Sumatriptan |
PK: AUC(0 ∞) of Lasmiditan and Sumatriptan was evaluated. |
| Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12, 24 ,36 and 48 h postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| 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 |
|
| 200 mg Lasmiditan + 100 mg Sumatriptan (A): |
Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg Sumatriptan tablet on day1. |
| OG001 | 200 mg Lasmiditan + Placebo (B) | Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet on day 1. |
| OG002 | 100 mg Sumatriptan + Placebo (C) | Participants received single oral dose of 100mg sumatriptan tablet and single oral dose of placebo tablet on day 1. |
| OG003 | Placebo + Placebo (D) | Participants received single oral dose of placebo for lasmiditan tablet and single oral dose of placebo for sumatriptan tablet on day 1. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan and Sumatriptan | PK: Cmax of Lasmiditan and Sumatriptan was evaluated. | All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 , 24 ,36 and 48 hours(h) postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0 ∞]) of Lasmiditan and Sumatriptan | PK: AUC(0 ∞) of Lasmiditan and Sumatriptan was evaluated. | All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12, 24 ,36 and 48 h postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 4 |
| 39 |
| EG001 | 200 mg Lasmiditan + Placebo (B) | Participants received single oral dose of 200mg lasmiditan tablet and single oral dose of placebo tablet on day 1. | 0 | 39 | 0 | 39 | 7 | 39 |
| EG002 | 100 mg Sumatriptan + Placebo (C) | Participants received single oral dose of 100mg sumatriptan tablet and single oral dose of placebo tablet on day 1. | 0 | 39 | 0 | 39 | 3 | 39 |
| EG003 | Placebo + Placebo (D) | Participants received single oral dose of placebo for lasmiditan tablet and single oral dose of placebo for sumatriptan tablet on day 1. | 0 | 40 | 0 | 40 | 1 | 40 |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
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.
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |