Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAHT | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the safety, tolerability and blood concentrations of lasmiditan and topiramate together compared to lasmiditan and topiramate separately. Information about any side effects that may occur will be collected.
Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start of the study and will remain through Day 14.
This study is expected to last approximately 25 days, not including screening. Screening is required within 28 days prior to the start of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasmiditan Alone | Experimental | Lasmiditan administered orally, alone |
|
| Placebo Alone | Placebo Comparator | Placebo administered orally, alone |
|
| Topiramate + Lasmiditan | Experimental | Topiramate administered orally, alone, and co-administered with oral lasmiditan |
|
| Topiramate + Placebo | Experimental | Topiramate administered orally, alone, and co-administered with oral placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Baseline through Day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate when administered alone on Day 13 and when coadministered with lasmiditan on Day 14 | Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 Madison CRU | Madison | Wisconsin | 53704 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: 50 mg Topiramate + Placebo | Placebo film-coated tablets administered orally once in the morning of Day 1 and once in the morning of Day 14. 25 milligrams (mg) topiramate administered orally on Day 3, two oral doses separated by approximately 12 hours of a single 25-mg topiramate tablet on Days 4 to 7, and two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13. Final topiramate dosing (2 25-mg tablets) was co-administered with 1 oral dose of placebo. |
| FG001 | Treatment Sequence 2: 50 mg Topiramate + 200 mg Lasmiditan | 200 mg lasmiditan film-coated tablet administered orally once in the morning of Day 1 and once in the morning of Day 14. 25 milligrams (mg) topiramate administered orally on Day 3, two oral doses separated by approximately 12 hours of a single 25-mg topiramate tablet on Days 4 to 7, and two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13. Final topiramate dosing (2 25-mg tablets) was co-administered with 1 oral dose of lasmiditan. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: 50 mg Topiramate + Placebo | Placebo film-coated tablets administered orally once in the morning of Day 1 and once in the morning of Day 14. Two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13. |
| BG001 | Treatment Sequence 2: 50 mg Topiramate + 200 mg 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 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Day 24 |
|
Up To 24 Days
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 200 mg Lasmiditan | Lasmiditan administered orally, alone | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lip dry | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2017 | Oct 31, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2017 | Oct 31, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C554777 | lasmiditan |
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered orally |
|
| Topiramate | Drug | Administered orally |
|
| PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours |
| PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 | PK: Area Under the Plasma Concentration versus Time Curve During One Dosing Interval (AUC [tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 | Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h) |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | PK: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours |
200 mg lasmiditan film-coated tablet administered orally once in the morning of Day 1 and once in the morning of Day 14. Two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13. |
| 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 |
|
| OG002 |
| Topiramate Alone |
Topiramate administered orally, alone |
| OG003 | 50 mg Topiramate + 200 mg Lasmiditan | Topiramate administered orally, alone, and co-administered with oral lasmiditan |
| OG004 | 50 mg Topiramate + Placebo | Topiramate administered orally, alone, and co-administered with oral placebo |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate when administered alone on Day 13 and when coadministered with lasmiditan on Day 14 | All participants who received at least one dose of lasmiditan or topiramate and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter (ng/mL) | Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h) |
|
|
|
| Secondary | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | All participants who received at least one dose of lasmiditan or topiramate and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter (ng/mL) | Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours |
|
|
|
| Secondary | PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 | PK: Area Under the Plasma Concentration versus Time Curve During One Dosing Interval (AUC [tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 | All participants who received at least one dose of lasmiditan or topiramate and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter(ng*h/mL) | Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h) |
|
|
|
| Secondary | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | PK: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | All participants who received at least one dose of lasmiditan or topiramate and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter(ng*h/mL) | Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours |
|
|
|
| 20 |
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | Placebo | Placebo administered orally, alone | 0 | 10 | 0 | 10 | 3 | 10 |
| EG002 | Topiramate Alone | Topiramate administered orally, alone | 0 | 30 | 0 | 30 | 5 | 30 |
| EG003 | 50 mg Topiramate + 200 mg Lasmiditan | Topiramate administered orally, alone, and co-administered with oral lasmiditan | 0 | 20 | 0 | 20 | 8 | 20 |
| EG004 | 50 mg Topiramate + Placebo | Topiramate administered orally, alone, and co-administered with oral placebo | 0 | 10 | 0 | 10 | 2 | 10 |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
| Carbohydrates |
| D007661 | Ketoses |