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| ID | Type | Description | Link |
|---|---|---|---|
| COL MIG-118 | Other Identifier | CoLucid Pharmaceuticals | |
| H8H-CD-LAHI | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| SNBL Clinical Pharmacology Center, Inc. | INDUSTRY |
| CoLucid Pharmaceuticals | INDUSTRY |
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This is a randomized, double-blind, three-period, cross-over study to investigate the effect of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of lasmiditan 200 mg.
This is a randomized, double-blind, three-period, cross-over study to investigate the effect of single doses of sumatriptan (Imitrex) 100 mg on the pharmacodynamics of single doses of lasmiditan 200 mg. The study will last approximately 6 weeks including up to 3 weeks for screening and 22 days on study. Screening will be conducted within approximately 21 days of the first dose of study medication. Each dosing period will last 3 days (Day 1, Day 1, and Day 2). A wash-out period of 6 days will take place between each dose. The End of Study Visit (EoS) will take place 5 (+/- 2) days after the third dosing period is completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasmiditan 200 mg | Experimental | single oral tablet |
|
| Sumatriptan 100 mg | Active Comparator | single oral tablet |
|
| Combination of lasmiditan and sumatriptan | Experimental | single oral tablet of each |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lasmiditan 200 mg | Drug | drug including single placebo tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Systolic Blood Pressure | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Diastolic Blood Pressure | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Pulse Rate | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Temperature | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Respiratory Rate | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Cmax | Maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period |
| Pharmacokinetics - AUC0-t |
Not provided
Inclusion Criteria:
Male or female aged 18-60 years, inclusive.
Able and willing to give written informed consent.
Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²), inclusive.
Participants must be able to refrain from consuming xanthine, quinine and caffeine containing beverages, and must refrain from prolonged intensive physical exercise during the study (from 72 hours prior to dosing until the end of study).
Women must be:
All females must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in on Day -1 of each period. All women must agree to use an adequate method of contraception during the study and for 30 days following the end-of-study.
Male participants must agree to utilize a highly effective method of contraception (condom plus spermicide) during heterosexual intercourse from clinic admission until 30 days following the end of study.
Male participants must agree to refrain from sperm donation from clinic admission until at least 30 days following the end of study.
Participants must be able to swallow multiple pills simultaneously.
Participants must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.
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 |
|---|---|---|---|---|---|---|
| SNBL Clinical Pharmacology Unit | Baltimore | Maryland | 21201 | United States |
Crossover study with three study periods, participants were randomly allocated to one of six treatment sequences: ABC, ACB, BAC, BCA, CAB or CBA as per the dosing sequence in each period with 6 days washout period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence ABC | Single oral doses of lasmiditan co-administered with single oral doses of sumatriptan (Imitrex) in the following sequence: Period 1 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. Period 2 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. Period 3 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg. |
| FG001 | Sequence ACB | Single oral doses of lasmiditan co-administered with single oral doses of Sumatriptan (Imitrex) in the following sequence: Period 1 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. Period 2 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg. Period 3 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. |
| FG002 | Sequence BCA | Single oral doses of lasmiditan co-administered with single oral doses of sumatriptan (Imitrex) in the following sequence: Period 1 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. Period 2 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg. Period 3 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. |
| FG003 | Sequence BAC | Single oral doses of lasmiditan co-administered with single oral doses of sumatriptan (Imitrex) in the following sequence: Period 1 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. Period 2 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. Period 3 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg. |
| FG004 | Sequence CAB | Single oral doses of lasmiditan co-administered with single oral doses of sumatriptan (Imitrex) in the following sequence: Period 1 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg. Period 2 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. Period 3 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. |
| FG005 | Sequence CBA | Single oral doses of lasmiditan co-administered with single oral doses of Sumatriptan (Imitrex) in the following sequence: Period 1 (C): lasmiditan 200 mg co-administered with sumatriptan (Imitrex) 100 mg. Period 2 (B): sumatriptan (Imitrex) 100 mg + lasmiditan 200 mg placebo. Period 3 (A): lasmiditan 200 mg + lasmiditan 200 mg placebo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Washout Period 1 |
| ||||||||||||||||
| Period 2 |
| ||||||||||||||||
| Washout Period 2 |
| ||||||||||||||||
| Period 3 |
| ||||||||||||||||
| Washout Period 3 |
|
All enrolled participants who received at least one dose of study drug (lasmiditan or sumatriptan).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Single oral doses of Lasmiditan 200 mg, lasmiditan 200 mg placebo and sumatriptan (Imitrex) 200 mg administered as per the dosing sequence in each period. |
| 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- Change From Pre-dose to 24 Hours in Vital Signs: Systolic Blood Pressure | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Pre-dose, 24 hours post-dose |
|
Up to 6 weeks
All participants who received at least one dose of study drug (lasmiditan or sumatriptan).
Not provided
| 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 single oral tablet of lasmiditan 200 mg with lasmiditan 200 mg placebo. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2017 | Feb 20, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2017 | Feb 20, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 | drug including single placebo tablet |
|
| matching placebo | Drug | single oral tablet -given with single lasmiditan tablet and with single sumatriptan tablet. |
|
| Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Heart Rate | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) PR Duration | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QRS Duration | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcB - Bazett's Correction Formula | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcF - Fridericia's Correction Formula | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QT Duration | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) RR Duration | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | Pre-dose, 24 hours post-dose |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety assessed from time of consent through end of study. A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the adverse events module of this record. | Up to 6 weeks |
Area under the plasma concentration versus time curve from time 0 to the time t of the last quantifiable concentration, calculated by means of the mixed log-linear trapezoidal rule of lasmiditan alone compare to lasmiditan in combination with sumatriptan. |
| Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period |
| Pharmacokinetics - Tmax | Time to maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 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 | Number | participants |
|
Participants received single oral tablet of sumatriptan 100 mg with lasmiditan 200 mg placebo. |
| OG002 | Combination of Lasmiditan and Sumatriptan | Participants received single oral tablet of lasmiditan 200 mg with sumatriptan 100 mg. |
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Diastolic Blood Pressure | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | mmHg | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Pulse Rate | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | beats/min | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Temperature | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | Celsius (C) | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Respiratory Rate | Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | breaths/min | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Heart Rate | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | beats/min | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) PR Duration | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | milliseconds (msec) | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QRS Duration | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | msec | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcB - Bazett's Correction Formula | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | msec | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcF - Fridericia's Correction Formula | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | msec | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QT Duration | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | msec | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) RR Duration | A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period. | Posted | Mean | Standard Deviation | msec | Pre-dose, 24 hours post-dose |
|
|
|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety assessed from time of consent through end of study. A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the adverse events module of this record. | All participants who received at least one dose of study drug (lasmiditan or sumatriptan). | Posted | Count of Participants | Participants | No | Up to 6 weeks |
|
|
|
| Secondary | Pharmacokinetics - Cmax | Maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan. | All participants who completed at least one treatment period without any protocol violations, who have evaluable plasma concentration data for lasmiditan and/or sumatriptan (Imitrex), and for whom at least a subset of the designated PK parameters can be determined. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period |
|
|
|
| Secondary | Pharmacokinetics - AUC0-t | Area under the plasma concentration versus time curve from time 0 to the time t of the last quantifiable concentration, calculated by means of the mixed log-linear trapezoidal rule of lasmiditan alone compare to lasmiditan in combination with sumatriptan. | All participants who completed at least one treatment period without any protocol violations, who have evaluable plasma concentration data for lasmiditan and/or sumatriptan (Imitrex), and for whom at least a subset of the designated PK parameters can be determined. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period |
|
|
|
| Secondary | Pharmacokinetics - Tmax | Time to maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan. | All participants who completed at least one treatment period without any protocol violations, who have evaluable plasma concentration data for lasmiditan and/or sumatriptan (Imitrex), and for whom at least a subset of the designated PK parameters can be determined. | Posted | Mean | Full Range | hour | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 24 |
| 41 |
| EG001 | Sumatriptan 100 mg | Participants received single oral tablet of sumatriptan 100 mg with lasmiditan 200 mg placebo. | 0 | 40 | 0 | 40 | 16 | 40 |
| EG002 | Combination of Lasmiditan and Sumatriptan | Participants received single oral tablet of lasmiditan 200 mg with sumatriptan 100 mg. | 0 | 42 | 0 | 42 | 28 | 42 |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 21.0 | 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.
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
|