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| ID | Type | Description | Link |
|---|---|---|---|
| CUD-P9-453 | Other Identifier | Algorithme Pharma | |
| H8H-CD-LAHF | Other Identifier | Eli Lilly and Company | |
| COL MIG-114 | Other Identifier | CoLucid Pharmaceuticals |
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| Name | Class |
|---|---|
| Algorithme Pharma Inc | INDUSTRY |
| CoLucid Pharmaceuticals | INDUSTRY |
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This is a multicenter, open-label, non-randomized, parallel-group, single dose study. This study will enroll up to 24 participants and will include 2 hepatic impaired participant groups and one group of control participants with normal hepatic function.
This study will enroll up to 24 participants and will include 2 hepatic impaired participant groups and one group of control participants with normal hepatic function. Approximately four participants with mild hepatic impairment will be enrolled first (Group 1). To ensure participant safety, following dosing of these first four participants, a safety meeting will take place to review the safety data prior to dosing additional participants. After safety and pharmacokinetic (PK) results from the first four participants have been reviewed, an additional four participants with mild hepatic impairment (remainder of Group 1) will be enrolled concurrently with the moderate hepatic impairment group (Group 2). Thereafter, matched participants with normal hepatic function (Group 3) will be enrolled. All participants will participate in one treatment period and will receive a single dose of lasmiditan in the fasting state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hepatic impairment | Experimental | lasmiditan 200 mg single dose |
|
| Moderate hepatic impairment | Experimental | lasmiditan 200 mg single dose |
|
| Healthy participants | Experimental | lasmiditan 200 mg single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lasmiditan 200 mg | Drug | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
| Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) | Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast]) | Cumulative area under the plasma concentration time curve calculated from 0 to TLQC using the linear trapezoidal method, where TLQC represents time of last observed quantifiable plasma concentration. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) | Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-tlast) + CLQC/λZ, where CLQC is the measured concentration at time TLQC Apparent elimination rate constant and λz is the estimated by linear regression of the terminal linear portion of the log concentration versus time curve. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
| Pharmacokinetics: Apparent Elimination Rate Constant (λZ) | Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety assessed from time of consent through end of study (up to 35 days). 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 35 days |
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Inclusion Criteria:
All participants:
Participants with Normal Hepatic Function:
Hepatic Impaired Participants:
Exclusion Criteria:
All Participants:
Participants with Normal Hepatic Function:
Hepatic Impaired Participants:
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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 |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States | ||
| NOCCR |
Male and female adult participants with normal hepatic function, mild and moderate hepatic impairment participated in the study. All participants participated in one treatment period and received a single dose of lasmiditan in the fasting state.Participants confined to the clinic 10 hours prior to dosing until 36 hours after drug administration.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mild Hepatic Impairment | Participants received lasmiditan 200 mg single oral dose in the fasting state. |
| FG001 | Moderate Hepatic Impairment | Participants received lasmiditan 200 mg single oral dose in the fasting state. |
| FG002 | Healthy Participants | Participants received lasmiditan 200 mg single oral dose in the fasting state. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Hepatic Impairment | Participants received lasmiditan 200 mg single oral dose in the fasting state. |
| BG001 | Moderate Hepatic Impairment | Participants received lasmiditan 200 mg single oral dose in the fasting state. |
| 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 | Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration. | All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
|
Up To 35 days
All enrolled participants who received at least one dose of the 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 | Mild Hepatic Impairment | Participants received lasmiditan 200 mg single oral dose in the fasting state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | 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 | Jan 9, 2016 | Feb 6, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2017 | Feb 6, 2019 | SAP_001.pdf |
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| 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 |
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This is a multicenter, open-label, non-randomized, parallel-group, single dose study.
This study will enroll up to 24 participants and will include 2 hepatic impaired participant groups and one group of control participants with normal hepatic function.
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| Pharmacokinetics: Terminal Elimination Half-life (T1/2) | Terminal elimination half-life, calculated as ln(2)/λZ. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
| Knoxville |
| Kentucky |
| 37920 |
| United States |
| Altasciences Company Inc./Algorithme Pharma | Mount Royal | Quebec | H3P 3P1 | Canada |
| BG002 | Healthy Participants | Participants received lasmiditan 200 mg single oral dose in the fasting state. |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| OG002 | Healthy Participants | Participants received lasmiditan 200 mg single oral dose in the fasting state |
|
|
| Primary | Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) | Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value. | All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data. | Posted | Median | Full Range | hours (hr) | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast]) | Cumulative area under the plasma concentration time curve calculated from 0 to TLQC using the linear trapezoidal method, where TLQC represents time of last observed quantifiable plasma concentration. | All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) | Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-tlast) + CLQC/λZ, where CLQC is the measured concentration at time TLQC Apparent elimination rate constant and λz is the estimated by linear regression of the terminal linear portion of the log concentration versus time curve. | All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Apparent Elimination Rate Constant (λZ) | Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve. | All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour (1/h) | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Terminal Elimination Half-life (T1/2) | Terminal elimination half-life, calculated as ln(2)/λZ. | All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data. | Posted | Geometric Mean | Full Range | hours (hr) | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety assessed from time of consent through end of study (up to 35 days). 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 enrolled participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | No | Up To 35 days |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Moderate Hepatic Impairment | Participants received lasmiditan 200 mg single oral dose in the fasting state. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG002 | Healthy Participants | Participants received lasmiditan 200 mg single oral dose in the fasting state. | 0 | 8 | 0 | 8 | 3 | 8 |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Somnolence | Nervous system 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 |
| Title | Measurements |
|---|---|
|