Phase 1
Completed N=40
A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT03310411 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Pharmacodynamics (PD): Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) — 13.81; 12.17; 13.63; 11.42 Millimeters of mercury (mmHg)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacodynamics (PD): Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) |
13.81; 12.17; 13.63; 11.42 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan and Sumatriptan |
304; 328; 56.8; 50.7 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0 ∞]) of Lasmiditan and Sumatriptan |
2110; 2170; 253; 240 | — |
Eligibility Criteria
Inclusion Criteria
- Are overtly healthy males or females, 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
- Have known allergies to Lasmiditan, Sumatriptan, related compounds, or any components of the formulations of Lasmiditan and Sumatriptan
- Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias
- Have a history, signs, or symptoms of arrhythmia or Wolff Parkinson White syndrome that could affect the participant's safety
- Have an estimated glomerular filtration rate (eGFR) of less than ( ) 135 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) >85 mmHg at screening
- Have a supine pulse rate (PR) of 90 beats per minute (bpm) at screening
- Have a history, signs, or symptoms of vasospastic coronary artery disease
- Have known or ongoing neuropsychiatric disorders (for example, manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator
- Use of monoamine oxidase-A inhibitors and other drugs associated with serotonin within the 3 months prior to the first dosing occasion
Data sourced from ClinicalTrials.gov (NCT03310411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.