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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-JE-LAIE | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in healthy Japanese and Caucasian participants. The study will also investigate how much lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan when given to Japanese and Caucasians. The study will last up to 47 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasmiditan - Japanese | Experimental | Single (50 milligram (mg), 100 mg, 200 mg, 400 mg) and repeated (2 × 200 mg) doses of Lasmiditan administered orally in up to three of three study periods. |
|
| Placebo - Japanese | Placebo Comparator | Single and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods. |
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| Lasmiditan - Caucasian | Experimental | Single (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods. |
|
| Placebo - Caucasian | Placebo Comparator | Single dose of Placebo administered orally in up to one of three study periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module. | Baseline up to Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period | PK: AUC(0-∞) of Lasmiditan in Each Period was evaluated. | Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours 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 | Dallas | Texas | 75247 | United States |
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Crossover study with three study periods, each participant received single/repeated oral doses of 50, 100, 200, 400, or 2 X 200 milligram (mg) lasmiditan, placebo, or 2 X placebo, according to their assigned treatment sequence, on Day 1 of each Period. The washout period between dosing in consecutive study periods was approximately 72 hours.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Sequence 1: Japanese | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan. |
| FG001 | Cohort 1: Sequence 2: Japanese | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan. |
| FG002 | Cohort 1: Sequence 3: Japanese | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo. |
| FG003 | Cohort 2: Sequence 1: Japanese | Participants received single, repeated oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart). |
| FG004 | Cohort 2: Sequence 2: Japanese | Participants received single, repeated oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart). |
| FG005 | Cohort 2: Sequence 3: Japanese | Participants received single oral doses of Lasmiditan and repeated oral doses of placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 100 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X Placebo (2 single doses administered 2 hours apart). |
| FG006 | Cohort 2: Sequence 4: Japanese | Participants received single, repeated oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence. Period 1: 200 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart). |
| FG007 | Cohort 3: Sequence 1: Caucasian | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan. |
| FG008 | Cohort 3: Sequence 2: Caucasian | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan. |
| FG009 | Cohort 3: Sequence 3: Caucasian | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo. |
| FG010 | Cohort 3: Sequence 4: Caucasian | Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan . |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Sequence 1: Japanese | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan. |
| BG001 | Cohort 1: Sequence 2: Japanese |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module. | All enrolled participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline up to Day 20 |
|
Up To 20 days
All enrolled 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 | Placebo: Japanese | Participants received single oral dose of placebo on day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | 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 | Apr 16, 2018 | Apr 23, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2018 | Apr 23, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
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| Placebo | Drug | Administered orally. |
|
| PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period | PK: Cmax of Lasmiditan in Each Period was evaluated. | Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan. |
| BG002 | Cohort 1: Sequence 3: Japanese | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo. |
| BG003 | Cohort 2: Sequence 1: Japanese | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart). |
| BG004 | Cohort 2: Sequence 2: Japanese | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart). |
| BG005 | Cohort 2: Sequence 3: Japanese | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 100 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X Placebo (2 single doses administered 2 hours apart). |
| BG006 | Cohort 2: Sequence 4: Japanese | Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence. Period 1: 200 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart). |
| BG007 | Cohort 3: Sequence 1: Caucasian | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan. |
| BG008 | Cohort 3: Sequence 2: Caucasian | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan. |
| BG009 | Cohort 3: Sequence 3: Caucasian | Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo. |
| BG010 | Cohort 3: Sequence 4: Caucasian | Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence. Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan . |
| BG011 | Total | Total of all reporting groups |
| Participants |
| No |
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| 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 | Number | participants |
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Participants received single oral dose of placebo on day 1.
| OG002 | 2 x Placebo: Japanese | Participants received 2 x Placebo (2 single oral doses administered 2 hours apart) on day 1. |
| OG003 | 50 mg Lasmiditan: Japanese | Participants received single oral dose of 50 mg lasmiditan on day 1. |
| OG004 | 50 mg Lasmiditan: Caucasian | Participants received single oral dose of 50 mg lasmiditan on day 1. |
| OG005 | 100 mg Lasmiditan: Japanese | Participants received single oral dose of 100 mg lasmiditan on day 1. |
| OG006 | 100 mg Lasmiditan: Caucasian | Participants received single oral dose of 100 mg lasmiditan on day 1. |
| OG007 | 200 mg Lasmiditan: Japanese | Participants received single oral dose of 200 mg lasmiditan on day 1 |
| OG008 | 200 mg Lasmiditan: Caucasian | Participants received single oral dose of 200 mg lasmiditan on day 1. |
| OG009 | 400 mg Lasmiditan: Japanese | Participants received single oral dose of 400 mg lasmiditan on day 1. |
| OG010 | 2 X 200 mg Lasmiditan: Japanese | Participants received 2 X 200 mg lasmiditan (2 single oral doses administered 2 hours apart) on day 1. |
|
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| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period | PK: AUC(0-∞) of Lasmiditan in Each Period 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*h/mL) | Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose |
|
|
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| Secondary | PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period | PK: Cmax of Lasmiditan in Each Period 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) | Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Placebo: Caucasian | Participants received single oral dose of placebo on day 1. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | 2 x Placebo: Japanese | Participants received 2 X Placebo (2 single oral doses administered 2 hours apart) on day 1. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | 50 mg Lasmiditan: Japanese | Participants received single oral dose of 50 mg lasmiditan on day 1. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | 50 mg Lasmiditan: Caucasian | Participants received single oral dose of 50 mg lasmiditan on day 1. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG005 | 100 mg Lasmiditan: Japanese | Participants received single oral dose of 100 mg lasmiditan on day 1. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG006 | 100 mg Lasmiditan: Caucasian | Participants received single oral dose of 100 mg lasmiditan on day 1. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG007 | 200 mg Lasmiditan: Japanese | Participants received single oral dose of 200 mg lasmiditan on day 1. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG008 | 200 mg Lasmiditan: Caucasian | Participants received single oral dose of 200 mg lasmiditan on day 1. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG009 | 400 mg Lasmiditan: Japanese | Participants received single oral dose of 400 mg lasmiditan on day 1. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG010 | 2 x 200 mg Lasmiditan: Japanese | Participants received 2 X 200 mg lasmiditan (2 single oral doses administered 2 hours apart) on day 1. | 0 | 7 | 0 | 7 | 5 | 7 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Joint warmth | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | 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.