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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAIA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to compare the amount of lasmiditan that gets into the blood stream and how long it takes the body to get rid of it, when given as a oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The information about any adverse effects experienced will be collected and the tolerability of lasmiditan when administered as OD tablet will also be evaluated.
Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 5 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 milligram (mg) Lasmiditan immediate release (IR) (Reference) | Active Comparator | Participants received 100 mg lasmiditan as IR tablet formulation administered orally. |
|
| 100 mg Lasmiditan oral disintegrating (OD) Without Water (Test) | Experimental | Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water. |
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| 100 mg Lasmiditan OD With Water (Test) | Experimental | Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | PK: Cmax of Lasmiditan. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan | PK: AUC[0-inf] of Lasmiditan. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose |
| PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan | PK: AUC[0-tlast] of Lasmiditan. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 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 Dallas | Dallas | Texas | 75247 | United States |
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Crossover study with three study periods, each participant received immediate release (IR) tablet as reference; oral disintegrating (OD) tablet with water and without water as test doses of 100 milligram (mg) lasmiditan according to their assigned treatment sequence, on Day 1 of each Period. The washout period between dosing in consecutive study periods was approximately 5 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan OD with water. |
| FG001 | Sequence 2 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan OD without water. |
| FG002 | Sequence 3 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan IR. |
| FG003 | Sequence 4 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD with water. |
| FG004 | Sequence 5 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD without water. |
| FG005 | Sequence 6 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan IR. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 1 Washout |
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| Period 2 |
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| Period 2 Washout |
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| Period 3 |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan OD with water. |
| BG001 | Sequence 2 |
| 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): Maximum Concentration (Cmax) of Lasmiditan | PK: Cmax of Lasmiditan. | All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose |
|
Baseline, Up to 49 days
All enrolled participants who received at least one dose of study drug (lasmiditan).
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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 | 100 mg Lasmiditan IR (Reference) | Participants received 100 mg lasmiditan as IR tablet formulation administered orally. |
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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 | Sep 8, 2020 | Mar 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2021 | Mar 7, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
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| COMPLETED |
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| NOT COMPLETED |
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| Received At Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Received At Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan OD without water. |
| BG002 | Sequence 3 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan IR. |
| BG003 | Sequence 4 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD with water. |
| BG004 | Sequence 5 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD without water. |
| BG005 | Sequence 6 | Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence: Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan IR. |
| BG006 | 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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| OG002 | 100 mg Lasmiditan OD With Water (Test) | Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water. |
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| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan | PK: AUC[0-inf] of Lasmiditan. | All enrolled participants who received at least one dose of study drug (lasmiditan) 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, 24, 48, 72, 96 and 120 hours post-dose |
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| Primary | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan | PK: AUC[0-tlast] of Lasmiditan. | All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose |
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|
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|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | 100 mg Lasmiditan OD Without Water (Test) | Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water. | 0 | 46 | 0 | 46 | 0 | 46 |
| EG002 | 100 mg Lasmiditan OD With Water (Test) | Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water. | 0 | 44 | 0 | 44 | 0 | 44 |
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| Ratio of Geometric least squares mean |
| 0.946 |
| 2-Sided |
| 90 |
| 0.914 |
| 0.978 |
| Equivalence |
Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect. |
| Ratio of Geometric least squares mean |
| 0.944 |
| 2-Sided |
| 90 |
| 0.913 |
| 0.977 |
| Equivalence |
Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect. |