Phase 1 Completed N=44 Basic Science

A Study of Lasmiditan and Propranolol in Healthy Participants

Healthy

Source: ClinicalTrials.gov NCT03270644 ↗

Enrolled (actual)

Serious AEs

0.8%

Results posted

Dec 2019

Primary outcomePrimary: Change From Baseline (Day 8) in Mean Hourly Heart Rate Following Propranolol Administered Alone and When Coadministered With Lasmiditan — 59.7; 54.2 beats per minute (bpm)

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline (Day 8) in Mean Hourly Heart Rate Following Propranolol Administered Alone and When Coadministered With Lasmiditan	59.7; 54.2	—
SECONDARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan Alone and When Coadministered With Propranolol	323; 290	—
SECONDARY Pharmacokinetic: Maximum Observed Drug Concentration (Cmax) of Propranolol Alone and When Coadministered With Lasmiditan	133; 127	—
SECONDARY Pharmacokinetic: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-tlast)] of Lasmiditan Alone and When Administered With Propranolol	2100; 2160	—
SECONDARY Pharmacokinetic: Area Under the Concentration Versus Time Curve (AUC) of Propranolol During One Dosing Interval Alone and When Administered With Lasmiditan	910; 910	—
SECONDARY Change From Baseline (Day 8) in PR Interval Following Propranolol Administered Alone and When Coadministered With Lasmiditan	165.6; 161.9	—
SECONDARY Change From Baseline (Day 8) in Systolic Blood Pressure Following Propranolol Administered Alone and When Coadministered With Lasmiditan	106.9; 112.4	—
SECONDARY Change From Baseline (Day 8) in Diastolic Blood Pressure Following Propranolol Administered Alone and When Coadministered With Lasmiditan	64.0; 67.4	—

Eligibility Criteria

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 ( ) 140 millimeters of mercury (mmHg) or diastolic blood pressure 90 mmHg at screening
Have a supine pulse rate of 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03270644). 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.