Trial · NCT04881747
A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants
NCT04881747, Phase 1, Completed, Eli Lilly and Company; results first posted 2023-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants. Trials, record NCT04881747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04881747
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants
- NCT number
- NCT04881747
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 47 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Healthy
- Interventions
- Lasmiditan
- First posted
- 2021-05-11
- Last updated
- 2023-03-23
- Results first posted
- 2023-03-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (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: Cmax of Lasmiditan. |
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (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: AUC\[0-inf\] of Lasmiditan. |
| Primary | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (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 | PK: AUC\[0-tlast\] of Lasmiditan. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetics (PK): Maximum Concentration (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 | All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (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 | All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data. | nanogram*hour per milliliter (ng*h/ mL) | GEOMETRIC_MEAN |
| PRIMARY | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (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 | All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data. | ng*h/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | 100 mg Lasmiditan IR (Reference) | 140 | Geometric Coefficient of Variation 43 | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | 100 mg Lasmiditan OD Without Water (Test) | 123 | Geometric Coefficient of Variation 42 | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | 100 mg Lasmiditan OD With Water (Test) | 124 | Geometric Coefficient of Variation 43 | nanograms per milliliter (ng/mL) | |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan | 100 mg Lasmiditan IR (Reference) | 937 | Geometric Coefficient of Variation 39 | 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 | 100 mg Lasmiditan OD Without Water (Test) | 884 | Geometric Coefficient of Variation 39 | 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 | 100 mg Lasmiditan OD With Water (Test) | 881 | Geometric Coefficient of Variation 39 | nanogram*hour per milliliter (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 | 100 mg Lasmiditan IR (Reference) | 915 | Geometric Coefficient of Variation 39 | 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 | 100 mg Lasmiditan OD Without Water (Test) | 860 | Geometric Coefficient of Variation 39 | 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 | 100 mg Lasmiditan OD With Water (Test) | 860 | Geometric Coefficient of Variation 39 | ng*h/mL |
Source ClinicalTrials.gov
Participant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Sequence 1 | 8 | |
| Period 1 | STARTED | Sequence 2 | 8 | |
| Period 1 | STARTED | Sequence 3 | 8 | |
| Period 1 | STARTED | Sequence 4 | 8 | |
| Period 1 | STARTED | Sequence 5 | 8 | |
| Period 1 | STARTED | Sequence 6 | 7 | |
| Period 1 | Received At Least One Dose of Study Drug | Sequence 1 | 8 | |
| Period 1 | Received At Least One Dose of Study Drug | Sequence 2 | 8 | |
| Period 1 | Received At Least One Dose of Study Drug | Sequence 3 | 8 | |
| Period 1 | Received At Least One Dose of Study Drug | Sequence 4 | 8 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 100 mg Lasmiditan IR (Reference) | 0 | 47 |
| Total, all-cause mortality | 100 mg Lasmiditan OD Without Water (Test) | 0 | 46 |
| Total, all-cause mortality | 100 mg Lasmiditan OD With Water (Test) | 0 | 44 |
| Total, other adverse events | 100 mg Lasmiditan IR (Reference) | 0 | 47 |
| Total, other adverse events | 100 mg Lasmiditan OD Without Water (Test) | 0 | 46 |
| Total, other adverse events | 100 mg Lasmiditan OD With Water (Test) | 0 | 44 |
| Total, serious adverse events | 100 mg Lasmiditan IR (Reference) | 0 | 47 |
| Total, serious adverse events | 100 mg Lasmiditan OD Without Water (Test) | 0 | 46 |
| Total, serious adverse events | 100 mg Lasmiditan OD With Water (Test) | 0 | 44 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04881747
GET https://conductscience.org/api/trials/v1/NCT04881747/flow?page=2