A Study of Lasmiditan and Propranolol in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Propranolol; Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03270644

16857

H8H-MC-LAHD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

44 participants in 3 patient groups

Lasmiditan Reference

Experimental group

Description:

Single oral dose of lasmiditan 200 mg on Day 1 as reference treatment.

Treatment:

Drug: Lasmiditan

Propranolol Reference

Active Comparator group

Description:

Twice-daily oral doses of propranolol 80 mg on Days 4-10 as reference treatment.

Treatment:

Drug: Propranolol

Lasmiditan + Propranolol Test

Experimental group

Description:

Single oral dose of lasmiditan 200 mg + two oral doses of propranolol 80 mg on Day 9 as test treatment.

Treatment:

Drug: Lasmiditan

Drug: Propranolol