A Study of Lasmiditan and Propranolol in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/8/2017 |
| Start Date: | August 31, 2017 |
| End Date: | November 22, 2017 |
Effect of Lasmiditan on Heart Rate and Blood Pressure in Healthy Subjects Receiving Oral Doses of Propranolol
This study will assess the effects on heart rate and blood pressure when a single dose of
lasmiditan is administered with a daily dose of propranolol. This study will also measure how
much lasmiditan gets into the bloodstream after taking lasmiditan alone and after taking it
together with propranolol. The study will also look at how well both drugs are tolerated.
Information about any side effects that may occur will be collected.
This study will last approximately 45 days including screening. This study will require 13
days/12 nights in a Clinical Research Unit (CRU) followed by 1 follow-up appointment
approximately 7 days after the last dose. Screening is required within 28 days prior to the
start of the study.
This study is for research purposes only and is not intended to treat any medical condition.
lasmiditan is administered with a daily dose of propranolol. This study will also measure how
much lasmiditan gets into the bloodstream after taking lasmiditan alone and after taking it
together with propranolol. The study will also look at how well both drugs are tolerated.
Information about any side effects that may occur will be collected.
This study will last approximately 45 days including screening. This study will require 13
days/12 nights in a Clinical Research Unit (CRU) followed by 1 follow-up appointment
approximately 7 days after the last dose. Screening is required within 28 days prior to the
start of the study.
This study is for research purposes only and is not intended to treat any medical condition.
Inclusion Criteria:
- Healthy males or females, as determined by medical history and physical examination
- Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²)
inclusive, at the time of screening
Exclusion Criteria:
- Have known allergies to lasmiditan, propranolol, related compounds or any components
of the formulation of lasmiditan or propranolol
- Have a history of, or electrocardiogram (ECG) findings of, clinically significant
bradycardia, heart block, tachy or brady arrhythmias, sick sinus syndrome/sinoatrial
block, or second or third-degree heart block, or have any other abnormality in the
12-lead ECG that, in the opinion of the investigator, increases the risks associated
with participating in the study
- Have an abnormal supine blood pressure, defined as systolic blood pressure less than
(<) 95 or greater than (>) 140 millimeters of mercury (mmHg) or diastolic blood
pressure <65 or >90 mmHg at screening
- Have a supine pulse rate of <50 or >90 beats per minute (bpm) at screening
- Have an estimated glomerular filtration rate (eGFR) of <60 milliliter per minute
(mL/min) per 1.73 meter squared (m2)
- Show evidence of significant active neuropsychiatric disease (for example, manic
depressive illness, schizophrenia, depression)
- Show a history of central nervous system (CNS) conditions such as strokes, transient
ischaemic attacks, significant head trauma, CNS infections, migraines, brain surgery
or any other neurological conditions that, in the opinion of the investigator,
increases the risk of participating in the study
- Are women with a positive pregnancy test or women who are lactating
We found this trial at
1
site
Daytona Beach, Florida 32117
Principal Investigator: Melanie Fein, MD
Phone: 386-366-6400
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