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NCT03310411 · ClinicalTrials.gov registry record · Phase 1
A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03310411: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT03310411 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03310411, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to assess whether taking lasmiditan and sumatriptan together will have any additional effects on heart rate and blood pressure compared to taking lasmiditan and sumatriptan individually. This study will also look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it when these two drugs are taken together. This study will last about 21 days, not including the screening. Participants will spend 16 days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is required within 28 days prior to the start of the study.
Primary Outcome
Systolic Blood Pressure (SBP) was measured by using a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least squares
Interventions
- DRUG Lasmiditan
- DRUG Sumatriptan
- DRUG Placebo for Lasmiditan
- DRUG Placebo for Sumatriptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-10-17 |
| Est. Completion | 2017-12-23 |
| Phase | Phase 1 |
What the finished NCT03310411 record still lists
NCT03310411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Lasmiditan is the first listed.
NCT03310411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03310411 about?
NCT03310411 is a clinical study titled "A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants". The purpose of this study is to assess whether taking lasmiditan and sumatriptan together will have any additional effects on heart rate and blood pressure compared to taking lasmiditan and sumatriptan individually. This study will also look at the amount of study drug that gets into the blood strea...
What is the current status of trial NCT03310411?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2017-10-17. Estimated completion is 2017-12-23.
What interventions are being tested in trial NCT03310411?
The interventions under investigation include: Lasmiditan (DRUG), Sumatriptan (DRUG), Placebo for Lasmiditan (DRUG), Placebo for Sumatriptan (DRUG).
Who is sponsoring clinical trial NCT03310411?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03310411's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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