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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAHD | Other Identifier | Eli Lilly and Company |
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This study will assess the effects on heart rate and blood pressure when a single dose of lasmiditan is administered with a daily dose of propranolol. This study will also measure how much lasmiditan gets into the bloodstream after taking lasmiditan alone and after taking it together with propranolol. The study will also look at how well both drugs are tolerated. Information about any side effects that may occur will be collected.
This study will last approximately 45 days including screening. This study will require 13 days/12 nights in a Clinical Research Unit (CRU) followed by 1 follow-up appointment approximately 7 days after the last dose. 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 |
|---|---|---|---|
| Lasmiditan Reference | Experimental | Single oral dose of lasmiditan 200 mg on Day 1 as reference treatment. |
|
| Propranolol Reference | Active Comparator | Twice-daily oral doses of propranolol 80 mg on Days 4-10 as reference treatment. |
|
| Lasmiditan + Propranolol Test | Experimental | Single oral dose of lasmiditan 200 mg + two oral doses of propranolol 80 mg on Day 9 as test treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Day 8) in Mean Hourly Heart Rate Following Propranolol Administered Alone and When Coadministered With Lasmiditan | Change from baseline in mean hourly heart rate recorded as beats per minute and collected by Holter ambulatory monitoring in response to propranolol administered alone and in combination with lasmiditan. | Baseline (Day 8), Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan Alone and When Coadministered With Propranolol | Maximum concentration of lasmiditan when administered alone on Day 1 and when coadministered with propranolol on Day 9. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
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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 |
Open-label fixed-sequence study in which participants received a single oral dose of lasmiditan 200 mg on Day (D) 1 Reference Treatment (R), then propranolol 80 mg administered orally twice daily from Day 4 through Day 10 Reference Treatment, with one single oral dose of lasmiditan 200 mg on Day 9 Test Treatment (T).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lasmiditan (R); Propranolol (R) + Lasmiditan (T) | Lasmiditan 200 mg single dose administered orally on D 1 (Reference); Propranolol 80 mg administered orally twice daily D4-10(Reference); Lasmiditan 200 mg administered orally on D9 (Test). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 Lasmiditan Reference |
|
| |||||||||||||||||||||
| Day 4 - 10 Propranolol Reference |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lasmiditan + Propranolol | Single 200 mg dose of lasmiditan administered orally on Day 1, then 80mg propranolol twice per day administered orally on Days 4 through 10, and 200 mg lasmiditan coadministered orally with propranolol on Day 9. |
| 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 | Change From Baseline (Day 8) in Mean Hourly Heart Rate Following Propranolol Administered Alone and When Coadministered With Lasmiditan | Change from baseline in mean hourly heart rate recorded as beats per minute and collected by Holter ambulatory monitoring in response to propranolol administered alone and in combination with lasmiditan. | All participants who had at least one dose of study drug and had baseline and post-baseline cardiovascular measurements. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline (Day 8), Day 9 |
|
Baseline through study completion (up to 23 days).
All participants who have 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 (Reference Treatment) | Lasmiditan 200 mg single dose administered orally on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal 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 | Oct 20, 2017 | Nov 20, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2017 | Nov 20, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Propranolol | Drug | Administered orally |
|
| Pharmacokinetic: Maximum Observed Drug Concentration (Cmax) of Propranolol Alone and When Coadministered With Lasmiditan |
Maximum concentration of propranolol when administered alone on Day 8 and when coadministered with lasmiditan on Day 9. |
| Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose |
| Pharmacokinetic: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-tlast)] of Lasmiditan Alone and When Administered With Propranolol | AUC versus time curve (AUC 0-tlast) of lasmiditan when administered alone on Day 1 and when coadministered with propranolol on Day 9. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
| Pharmacokinetic: Area Under the Concentration Versus Time Curve (AUC) of Propranolol During One Dosing Interval Alone and When Administered With Lasmiditan | AUC versus time curve of propranolol during one dosing interval when administered alone on Day 8 and when administered with lasmiditan on Day 9. | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose |
| Change From Baseline (Day 8) in PR Interval Following Propranolol Administered Alone and When Coadministered With Lasmiditan | Change from baseline in PR interval, the interval between the P wave and the QRS complex calculated from electrocardiogram (ECG) data. | Baseline (Day 8), Day 9 |
| Change From Baseline (Day 8) in Systolic Blood Pressure Following Propranolol Administered Alone and When Coadministered With Lasmiditan | Change from baseline in systolic blood pressure was measured in supine position. | Baseline (Day 8), Day 9 |
| Change From Baseline (Day 8) in Diastolic Blood Pressure Following Propranolol Administered Alone and When Coadministered With Lasmiditan | Change from baseline in diastolic blood pressure was measured in supine position. | Baseline (Day 8), Day 9 |
| COMPLETED |
|
| 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 |
|
| Mean Hourly Heart Rate | All participants who received one dose of study drug and had hourly HR baseline data. | Mean | Standard Deviation | beats per minute (BPM) |
|
Lasmiditan 200 mg coadministered with propranolol 80 mg on Day 9. |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan Alone and When Coadministered With Propranolol | Maximum concentration of lasmiditan when administered alone on Day 1 and when coadministered with propranolol on Day 9. | All participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per mililiter (ng/mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
|
|
|
|
| Secondary | Pharmacokinetic: Maximum Observed Drug Concentration (Cmax) of Propranolol Alone and When Coadministered With Lasmiditan | Maximum concentration of propranolol when administered alone on Day 8 and when coadministered with lasmiditan on Day 9. | All participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose |
|
|
|
|
| Secondary | Pharmacokinetic: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-tlast)] of Lasmiditan Alone and When Administered With Propranolol | AUC versus time curve (AUC 0-tlast) of lasmiditan when administered alone on Day 1 and when coadministered with propranolol on Day 9. | All participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms * hour/mL (ng*h/mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
|
|
|
|
| Secondary | Pharmacokinetic: Area Under the Concentration Versus Time Curve (AUC) of Propranolol During One Dosing Interval Alone and When Administered With Lasmiditan | AUC versus time curve of propranolol during one dosing interval when administered alone on Day 8 and when administered with lasmiditan on Day 9. | All participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose |
|
|
|
|
| Secondary | Change From Baseline (Day 8) in PR Interval Following Propranolol Administered Alone and When Coadministered With Lasmiditan | Change from baseline in PR interval, the interval between the P wave and the QRS complex calculated from electrocardiogram (ECG) data. | All participants who had at least one dose of study drug and had evaluable baseline and post-baseline cardiovascular measurements. | Posted | Mean | Standard Deviation | millisecond (msec) | Baseline (Day 8), Day 9 |
|
|
|
|
| Secondary | Change From Baseline (Day 8) in Systolic Blood Pressure Following Propranolol Administered Alone and When Coadministered With Lasmiditan | Change from baseline in systolic blood pressure was measured in supine position. | All participants who had at least one dose of study drug and had evaluable baseline and post-baseline cardiovascular measurements. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline (Day 8), Day 9 |
|
|
|
|
| Secondary | Change From Baseline (Day 8) in Diastolic Blood Pressure Following Propranolol Administered Alone and When Coadministered With Lasmiditan | Change from baseline in diastolic blood pressure was measured in supine position. | All participants who had at least one dose of study drug and had evaluable baseline and post-baseline cardiovascular measurements. | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 8), Day 9 |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 9 |
| 44 |
| EG001 | Propranolol 80 mg (Reference Treatment) | Propranolol 80 mg administered orally twice daily on Day 4 to Day 10. | 0 | 43 | 1 | 43 | 1 | 43 |
| EG002 | Lasmiditan 200 mg + Propranolol 80 mg (Test Treatment) | Lasmiditan 200 mg coadministered orally with propranolol 80 mg on Day 9. | 0 | 42 | 0 | 42 | 7 | 42 |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |