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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-CD-LAHH | Other Identifier | Eli Lilly and Company | |
| COL MIG-110 | Other Identifier | CoLucid Pharmaceuticals |
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| Name | Class |
|---|---|
| CoLucid Pharmaceuticals | INDUSTRY |
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This study will be an open-label, nonrandomized, absorption, metabolism, and excretion study of [14C]-lasmiditan administered as a 200-milligrams (mg) (approximately 100 microcuries[µCi]) oral solution to 8 healthy males and females, following at least a 10 hour fast from food to assess the pharmacokinetics (PK), metabolism, and routes and extent of elimination of a single oral dose of 200 mg (approximately 100 µCi) [14C] lasmiditan in healthy males and females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-lasmiditan | Experimental | [14C]-lasmiditan administered as a 200 mg (approximately 100 µCi) oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-lasmiditan | Drug | [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) | Maximum observed concentration based on plasma concentrations of lasmiditan. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose |
| Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) | Time to maximum concentration based on plasma concentrations of lasmiditan. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast]) | Area under concentration time curve (AUC) from Hour 0 to the last measurable concentration based on plasma concentrations of lasmiditan. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose |
| AUC Time Zero to Infinity (AUC0-∞) Blood/Plasma Ratio | AUC time zero to infinity (0-∞) of total radioactivity in blood/AUC0-∞ of total radioactivity in plasma. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose |
| AUC Time Zero to Infinity (AUC0-∞) Plasma Lasmiditan/Total Radioactivity Ratio | AUC time zero to infinity (0-∞) of lasmiditan in plasma/AUC0-∞ of total radioactivity in plasma. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Cumulative Amount of Lasmiditan and Its Metabolites Excreted in Urine | Amount of Lasmiditan and its metabolites (M3, M7, M8, (S,R)-M18, and (S,S)-M18) excreted in urine (Aeu) over sampling interval. | Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 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 Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
Participants were preceded by an overnight fast (at least 10 hours) from food (not including water) before receiving a dose of [14C]-lasmiditan.
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| ID | Title | Description |
|---|---|---|
| FG000 | [14C]-Lasmiditan | Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1. |
| 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 | [14C]-Lasmiditan | Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1. |
| 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: Maximum Observed Plasma Concentration (Cmax) | Maximum observed concentration based on plasma concentrations of lasmiditan. | All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose |
|
|
Up To 49 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
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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 | [14C]-Lasmiditan | Participants were administered a single oral dose of radiolabeled [14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| External ear pain | Ear and labyrinth 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 | Jan 23, 2017 | Feb 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2017 | Feb 7, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
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| Percentage of Lasmiditan Recovered in Urine, Relative to Dose Administered | Percentage of lasmiditan recovered in urine (%UR), relative to dose administered calculated as %UR = 100 (amount of lasmiditan excreted in urine over a sampling interval (Aeu)/dose). | Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose |
| Renal Clearance (CLR) | Renal clearance is the volume of plasma completely cleared of lasmiditan by the kidneys per unit time and calculated as CLR = Aeu/AUC0-x (where Aeu = amount of lasmiditan excreted in urine over a sampling interval; x is the last interval collected; for lasmiditan only). | Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 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 (up to 49 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 49 days |
| 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 |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) | Time to maximum concentration based on plasma concentrations of lasmiditan. | All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data. | Posted | Median | Full Range | hours (hr) | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast]) | Area under concentration time curve (AUC) from Hour 0 to the last measurable concentration based on plasma concentrations of lasmiditan. | All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose |
|
|
|
| Primary | AUC Time Zero to Infinity (AUC0-∞) Blood/Plasma Ratio | AUC time zero to infinity (0-∞) of total radioactivity in blood/AUC0-∞ of total radioactivity in plasma. | All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose |
|
|
|
| Primary | AUC Time Zero to Infinity (AUC0-∞) Plasma Lasmiditan/Total Radioactivity Ratio | AUC time zero to infinity (0-∞) of lasmiditan in plasma/AUC0-∞ of total radioactivity in plasma. | All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose |
|
|
|
| Secondary | Pharmacokinetics - Cumulative Amount of Lasmiditan and Its Metabolites Excreted in Urine | Amount of Lasmiditan and its metabolites (M3, M7, M8, (S,R)-M18, and (S,S)-M18) excreted in urine (Aeu) over sampling interval. | All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data. | Posted | Mean | Standard Deviation | milligram (mg) | Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose |
|
|
|
| Secondary | Percentage of Lasmiditan Recovered in Urine, Relative to Dose Administered | Percentage of lasmiditan recovered in urine (%UR), relative to dose administered calculated as %UR = 100 (amount of lasmiditan excreted in urine over a sampling interval (Aeu)/dose). | All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data. | Posted | Mean | Standard Deviation | % of lasmiditan dose | Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose |
|
|
|
| Secondary | Renal Clearance (CLR) | Renal clearance is the volume of plasma completely cleared of lasmiditan by the kidneys per unit time and calculated as CLR = Aeu/AUC0-x (where Aeu = amount of lasmiditan excreted in urine over a sampling interval; x is the last interval collected; for lasmiditan only). | All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data. | Posted | Mean | Standard Deviation | liter per hour (L/hr) | Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 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 49 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 and had at least 1 post-dose safety assessment. | Posted | Count of Participants | Participants | No | Up to 49 days |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 5 |
| 8 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Feeling drunk | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Post procedural contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | 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.
| Title | Measurements |
|---|---|
|
| M8 |
|
| (S,R)-M18 |
|
| (S,S)-M18 |
|