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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAIC | Other Identifier | Eli Lilly and Company |
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This is a study of lasmiditan in healthy Chinese participants. The purposes are:
The study will last up to 50 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing). |
|
| 50 milligram (mg) Lasmiditan | Experimental | Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
|
| 100 mg Lasmiditan | Experimental | Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
|
| 200 mg Lasmiditan | Experimental | Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan | PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1). | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose |
| PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10). | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) |
| PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10). | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10). | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 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 |
|---|---|---|---|---|---|---|
| HuaShan Hospital Affiliated To Fudan University | Shanghai | Shanghai Municipality | 20040 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing). |
| FG001 | 50 Milligram (mg) Lasmiditan | Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
| FG002 | 100 mg Lasmiditan | Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
| FG003 | 200 mg Lasmiditan | Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing). |
| BG001 | 50 mg Lasmiditan | Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
| 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, 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 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan | PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1). | All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic 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, and 24 hours post-dose |
|
Baseline, Up to 4 months
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 | Placebo | Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 22.0 | 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 | Feb 1, 2019 | Jun 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2018 | Jun 2, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
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| Placebo | Drug | Administered orally |
|
| BG002 | 100 mg Lasmiditan | Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
| BG003 | 200 mg Lasmiditan | Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
| BG004 | Total | Total of all reporting groups |
| years |
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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 | Count of Participants | Participants | No |
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| OG001 | 100 mg Lasmiditan | Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
| OG002 | 200 mg Lasmiditan | Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. |
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|
| Primary | PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10). | All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) |
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| Primary | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10). | All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) |
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| Primary | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10). | All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data. | Posted | Median | Full Range | hours (h) | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) |
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | 50 mg Lasmiditan | Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. | 0 | 10 | 0 | 10 | 9 | 10 |
| EG002 | 100 mg Lasmiditan | Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG003 | 200 mg Lasmiditan | Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. | 0 | 10 | 0 | 10 | 8 | 10 |
| Sinus bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Puncture site swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Electrocardiogram qt prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Heart rate decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Lymphocyte percentage decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Neutrophil percentage decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Neutrophil percentage increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Protein urine present | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Red blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Red blood cells urine positive | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Urinary casts | Investigations | MedDRA 22.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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