A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/21/2018 |
| Start Date: | October 17, 2017 |
| End Date: | December 23, 2017 |
A Randomized, Double-Blind, Four-Period, Crossover Study to Evaluate the Cardiovascular Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Subjects
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.
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.
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 (<) 60 milliliter per
minute (mL/min) per 1.73 m²
- Have a resting systolic blood pressure (SBP) greater than (>) 135 millimeters of
mercury (mmHg) and diastolic blood pressure (DBP) >85 mmHg at screening
- Have a supine pulse rate (PR) of <50 or >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
We found this trial at
1
site
Daytona Beach, Florida 32117
Principal Investigator: Melanie Fein, MD
Phone: 866-429-3700
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