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CompletedNCT03308669Updated Nov 27, 2019Results posted

A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate

A Phase 1 interventional study of Lasmiditan and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-27.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Are healthy males or females (of non-child bearing potential), as determined by medical history and physical examination
  • Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

Exclusion criteria

Exclusion Criteria:

  • Have known allergies to lasmiditan, topiramate, related compounds or any components of the formulation of lasmiditan or topiramate
  • Have an abnormal supine blood pressure, defined as systolic blood pressure less than (\<) 90 or great (>) 140 millimeters of mercury (mmHg) or diastolic blood pressure \<60 or >90 mmHg at screening
  • Have known or ongoing psychiatric disorders considered clinically significant by the investigator or demonstrate suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)
  • Have a clinically significant abnormality in the neurological examination
  • Have current or a history of orthostatic hypotension (>20-mmHg drop in systolic blood pressure, or >10-mmHg drop in diastolic blood pressure) with or without dizziness and/or syncope at screening or admission to the Clinical Research Unit (CRU) upon repeat testing
  • Have an estimated glomerular filtration rate using Modification of Diet in Renal Disease \<60 milliliter per minute (mL/min) per 1.73 meter squared (m²)
  • Have a history of glaucoma
  • Have a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Lasmiditan Alone

    Lasmiditan administered orally, alone

    Drug: Lasmiditan

  • Placebo comparator
    Placebo Alone

    Placebo administered orally, alone

    Drug: Placebo

  • Experimental
    Topiramate + Lasmiditan

    Topiramate administered orally, alone, and co-administered with oral lasmiditan

    Drug: Lasmiditan · Drug: Topiramate

  • Experimental
    Topiramate + Placebo

    Topiramate administered orally, alone, and co-administered with oral placebo

    Drug: Placebo · Drug: Topiramate

Interventions

  • DrugLasmiditan

    Administered orally

    Also known as: LY573144

  • DrugPlacebo

    Administered orally

  • DrugTopiramate

    Administered orally

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline through Day 24

Secondary outcomes

  1. 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

    Time frame: Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)

  2. 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

    Time frame: Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

  3. 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

    Time frame: Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)

  4. 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

    Time frame: Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

06

Results

Posted Nov 27, 2019

Participant flow

Participant flow — Overall Study
MilestoneTreatment Sequence 1: 50 mg Topiramate + PlaceboTreatment Sequence 2: 50 mg Topiramate + 200 mg Lasmiditan
Started1020
Received at least one dose of study drug1020
Completed1020
Not completed00

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline through Day 24
Reported as:
Count of participants · Participants
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
ParticipantsPlacebo200 mg LasmiditanTopiramate Alone50 mg Topiramate + 200 mg Lasmiditan50 mg Topiramate + Placebo
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration00000
SecondaryPharmacokinetics (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

Time frame:
Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)
Reported as:
Geometric mean · Nanogram/milliliter (ng/mL)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14
Nanogram/milliliter (ng/mL)50 mg Topiramate50 mg Topiramate + 200 mg Lasmiditan
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 144300 ± 154190 ± 16
SecondaryPK: 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

Time frame:
Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Reported as:
Geometric mean · Nanogram/milliliter (ng/mL)
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14
Nanogram/milliliter (ng/mL)200 mg Lasmiditan50 mg Topiramate + 200 mg Lasmiditan
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14276 ± 41301 ± 35
SecondaryPK: 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

Time frame:
Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)
Reported as:
Geometric mean · nanograms*hour per milliliter(ng*h/mL)
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
nanograms*hour per milliliter(ng*h/mL)50 mg Topiramate50 mg Topiramate + 200 mg Lasmiditan
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 1442600 ± 1542800 ± 17
SecondaryPK: 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

Time frame:
Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Reported as:
Geometric mean · nanograms*hour per milliliter(ng*h/mL)
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
nanograms*hour per milliliter(ng*h/mL)200 mg Lasmiditan50 mg Topiramate + 200 mg Lasmiditan
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 141860 ± 292050 ± 29

Adverse events

Collected over Up To 24 Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
200 mg Lasmiditan0/20 (0%)0/20 (0%)8/20 (40%)
Placebo0/10 (0%)0/10 (0%)3/10 (30%)
Topiramate Alone0/30 (0%)0/30 (0%)5/30 (16.7%)
50 mg Topiramate + 200 mg Lasmiditan0/20 (0%)0/20 (0%)8/20 (40%)
50 mg Topiramate + Placebo0/10 (0%)0/10 (0%)2/10 (20%)
Most frequent other events
Most frequent other events
Event200 mg LasmiditanPlaceboTopiramate Alone50 mg Topiramate + 200 mg Lasmiditan50 mg Topiramate + Placebo
DizzinessNervous system disorders7/201/100/305/201/10
SomnolenceNervous system disorders2/200/102/303/200/10
Lip dryGastrointestinal disorders0/201/100/300/200/10
FatigueGeneral disorders1/201/101/300/200/10
Depressed moodPsychiatric disorders0/200/100/300/201/10
Euphoric moodPsychiatric disorders2/201/101/301/200/10
ScratchInjury, poisoning and procedural complications0/200/102/300/200/10
Disturbance in attentionNervous system disorders0/200/102/301/200/10

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)Treatment Sequence 1: 50 mg Topiramate + PlaceboTreatment Sequence 2: 50 mg Topiramate + 200 mg LasmiditanTotal
Mean44.3 ± 13.344.0 ± 13.644.1 ± 13.3
Sex: Female, Male
Sex: Female, Male(Participants)Treatment Sequence 1: 50 mg Topiramate + PlaceboTreatment Sequence 2: 50 mg Topiramate + 200 mg LasmiditanTotal
Female011
Male101929
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment Sequence 1: 50 mg Topiramate + PlaceboTreatment Sequence 2: 50 mg Topiramate + 200 mg LasmiditanTotal
Hispanic or Latino011
Not Hispanic or Latino101929
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment Sequence 1: 50 mg Topiramate + PlaceboTreatment Sequence 2: 50 mg Topiramate + 200 mg LasmiditanTotal
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American11011
White9817
More than one race011
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Treatment Sequence 1: 50 mg Topiramate + PlaceboTreatment Sequence 2: 50 mg Topiramate + 200 mg LasmiditanTotal
United States102030
07

Study locations

1 site
  • Covance Madison CRU
    Madison, Wisconsin 53704, United States
08

References and documents

Study documents

  • Study protocol · Oct 20, 2017
  • Statistical analysis plan · Nov 1, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03308669
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 12, 2017
Start date
Oct 16, 2017
Primary completion
Dec 2, 2017
Completion
Dec 2, 2017
Results posted
Nov 27, 2019
Last update
Nov 27, 2019

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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