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CompletedNCT04881747Updated Mar 23, 2023Results posted

A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants

A Phase 1 interventional study of Lasmiditan 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 2023-03-23.

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

Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • Are overtly healthy as determined by medical evaluation.
  • Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).

Exclusion criteria

Exclusion Criteria:

  • Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy.
  • Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.
  • Have clinically significant abnormalities on ECG, as determined by investigator.
  • Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data.
  • Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Active comparator
    100 milligram (mg) Lasmiditan immediate release (IR) (Reference)

    Participants received 100 mg lasmiditan as IR tablet formulation administered orally.

    Drug: Lasmiditan

  • Experimental
    100 mg Lasmiditan oral disintegrating (OD) Without Water (Test)

    Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.

    Drug: Lasmiditan

  • Experimental
    100 mg Lasmiditan OD With Water (Test)

    Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.

    Drug: Lasmiditan

Interventions

  • DrugLasmiditan

    Administered orally.

    Also known as: LY573144

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan

    PK: Cmax of Lasmiditan.

    Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose

  2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan

    PK: AUC\[0-inf\] of Lasmiditan.

    Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose

  3. 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.

    Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose

07

Results

Posted Mar 23, 2023

Participant flow

Period 1
Participant flow — Period 1
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Started888887
Received at least one dose of study drug888887
Completed888887
Not completed000000
Period 1 Washout
Participant flow — Period 1 Washout
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Started888887
Completed888887
Not completed000000
Period 2
Participant flow — Period 2
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Started888887
Received at least one dose of study drug888887
Completed888887
Not completed000000
Period 2 Washout
Participant flow — Period 2 Washout
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Started888887
Completed688777
Not completed200110
Withdrew: Adverse event100010
Withdrew: Withdrawal by subject100100
Period 3
Participant flow — Period 3
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Started688777
Received at least one dose of study drug688777
Completed688777
Not completed000000

Outcome measures

PrimaryPharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan

PK: Cmax of Lasmiditan.

Time frame:
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
Reported as:
Geometric mean · nanograms per milliliter (ng/mL)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
nanograms per milliliter (ng/mL)100 mg Lasmiditan IR (Reference)100 mg Lasmiditan OD Without Water (Test)100 mg Lasmiditan OD With Water (Test)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan140 ± 43123 ± 42124 ± 43
Statistical analysis
  • 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD Without Water (Test) · Ratio of geometric least squares mean: 0.875 · 90% CI 0.834 to 0.919
  • 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD With Water (Test) · Ratio of geometric least squares mean: 0.889 · 90% CI 0.846 to 0.934
PrimaryPK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan

PK: AUC\[0-inf\] of Lasmiditan.

Time frame:
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
Reported as:
Geometric mean · nanogram*hour per milliliter (ng*h/ mL)
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan
nanogram*hour per milliliter (ng*h/ mL)100 mg Lasmiditan IR (Reference)100 mg Lasmiditan OD Without Water (Test)100 mg Lasmiditan OD With Water (Test)
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan937 ± 39884 ± 39881 ± 39
Statistical analysis
  • 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD Without Water (Test) · Ratio of geometric least squares mean: 0.944 · 90% CI 0.914 to 0.976
  • 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD With Water (Test) · Ratio of geometric least squares mean: 0.946 · 90% CI 0.914 to 0.978
PrimaryPK: 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.

Time frame:
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
Reported as:
Geometric mean · ng*h/mL
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan
ng*h/mL100 mg Lasmiditan IR (Reference)100 mg Lasmiditan OD Without Water (Test)100 mg Lasmiditan OD With Water (Test)
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan915 ± 39860 ± 39860 ± 39
Statistical analysis
  • 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD Without Water (Test) · Ratio of geometric least squares mean: 0.941 · 90% CI 0.910 to 0.972
  • 100 mg Lasmiditan IR (Reference) vs 100 mg Lasmiditan OD With Water (Test) · Ratio of geometric least squares mean: 0.944 · 90% CI 0.913 to 0.977

Adverse events

Collected over Baseline, Up to 49 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
100 mg Lasmiditan IR (Reference)0/47 (0%)0/47 (0%)0/47 (0%)
100 mg Lasmiditan OD Without Water (Test)0/46 (0%)0/46 (0%)0/46 (0%)
100 mg Lasmiditan OD With Water (Test)0/44 (0%)0/44 (0%)0/44 (0%)

Baseline characteristics

All enrolled participants.

Age, Continuous
Age, Continuous(years)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
Mean40.6 ± 13.335.6 ± 12.540.6 ± 14.335.8 ± 12.643.5 ± 11.547.3 ± 12.540.4 ± 12.8
Sex: Female, Male
Sex: Female, Male(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
Female23423216
Male65465531
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
Hispanic or Latino12212210
Not Hispanic or Latino76676537
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
American Indian or Alaska Native0000000
Asian0001102
Native Hawaiian or Other Pacific Islander0000000
Black or African American54544224
White34333521
More than one race0000000
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
United States88888747
08

Study locations

1 site
  • Covance Dallas
    Dallas, Texas 75247, United States
09

References and documents

Study documents

  • Study protocol · Sep 8, 2020
  • Statistical analysis plan · Mar 10, 2021

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

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04881747
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
May 11, 2021
Start date
May 14, 2021
Primary completion
Jul 24, 2021
Completion
Jul 24, 2021
Results posted
Mar 23, 2023
Last update
Mar 23, 2023

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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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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