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| ID | Type | Description | Link |
|---|---|---|---|
| CUD-P4-001 | Other Identifier | Algorithme Pharma | |
| COl MIG-113 | Other Identifier | CoLucid Pharmaceuticals | |
| H8H-CD-LAHN | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| CoLucid Pharmaceuticals | INDUSTRY |
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This is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose study.
This study will enroll up to 32 participants using an adaptive design that can include up to 3 groups of 8 participants with different degree of renal impairment and one group of 8 control participants with normal renal function.
Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered in the study.
First, approximately 16 participants will be enrolled with severe renal impairment and matched participants with normal renal function. There will be 8 participants in each of the following groups based on renal function at screening:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal impaired participants | Experimental | Participants received single 200 milligrams (mg) oral tablet of lasmiditan. |
|
| Healthy participants | Experimental | Participants received single 200 mg oral tablet of lasmiditan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | 200 mg, single oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration of lasmiditan. | Predose, 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, postdose |
| 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 | Predose, 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, postdose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast]) | Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC[0- tlast]) of lasmiditan. | Predose, 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, postdose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) | Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC[0-inf]) of lasmiditan. | Predose, 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, postdose |
| Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t]) | Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine) | Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose |
| Pharmacokinetics: Fraction of Dose Excreted in Urine (fe) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record. |
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Inclusion Criteria:
Participants with Normal Renal Function:
Renal Impaired Participants:
Exclusion Criteria:
All Participants:
Participants with Normal Renal Function:
Renal 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 |
|---|---|---|---|---|---|---|
| CIUSSS de l'est-de-l'île-de-Montréal - installation Hôpital Maisonneuve-Rosemont | Montreal | Quebec | H3P3P1 | Canada | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants | Participants received single 200 milligrams (mg) oral dose of lasmiditan. |
| FG001 | Renal Impaired Participants | Participants received single 200 mg oral dose of lasmiditan. |
| 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 | Healthy Participants | Participants received single 200 milligrams (mg) oral dose of lasmiditan. |
| BG001 | Renal Impaired Participants | Participants received single 200 mg oral dose of lasmiditan. |
| 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 plasma concentration of lasmiditan. | All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetics (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose, 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, postdose |
|
Up To 7 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 | Healthy Participants | Participants received single 200 mg oral dose of lasmiditan. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | 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 6, 2017 | Nov 27, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2018 | Nov 27, 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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Fraction of dose excreted in urine (Ae / dose)
| Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose |
| Pharmacokinetics: Renal Clearance (CLr) | Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T) | Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose |
| Up To 7 days |
| Algorithme Pharma |
| Mount Royal |
| Quebec |
| H3P3P1 |
| Canada |
| BG002 | 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 |
|
|
|
| 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 study drug and have evaluable PK data. | Posted | Median | Full Range | hours (h) | Predose, 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, postdose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast]) | Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC[0- tlast]) of lasmiditan. | All enrolled participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Predose, 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, postdose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) | Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC[0-inf]) of lasmiditan. | All enrolled participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 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, postdose |
|
|
|
| Primary | Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t]) | Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine) | All enrolled participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams (mg) | Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose |
|
|
|
| Primary | Pharmacokinetics: Fraction of Dose Excreted in Urine (fe) | Fraction of dose excreted in urine (Ae / dose) | All enrolled participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose |
|
|
|
| Primary | Pharmacokinetics: Renal Clearance (CLr) | Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T) | All enrolled participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour (L/h) | Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record. | All enrolled participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Up To 7 days |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 6 |
| 8 |
| EG001 | Renal Impaired Participants | Participants received single 200 mg oral dose of lasmiditan. | 0 | 8 | 0 | 8 | 6 | 8 |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vessel puncture site erythema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Foreign body in respiratory tract | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Procedural anxiety | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular 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 |