A Study of Lasmiditan and Propranolol in Healthy Participants

NCT ID: NCT03270644

Last Updated: 2019-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2017-11-22

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lasmiditan Reference

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

Group Type: EXPERIMENTAL

Lasmiditan

Intervention Type: DRUG

Administered orally

Propranolol Reference

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

Group Type: ACTIVE_COMPARATOR

Propranolol

Intervention Type: DRUG

Administered orally

Lasmiditan + Propranolol Test

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

Group Type: EXPERIMENTAL

Lasmiditan

Intervention Type: DRUG

Administered orally

Propranolol

Intervention Type: DRUG

Administered orally

Interventions

Lasmiditan

Administered orally

Intervention Type: DRUG

Propranolol

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY573144

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 (<) 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Covance Daytona Beach

Daytona Beach, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H8H-MC-LAHD

Identifier Type: OTHER

Identifier Source: secondary_id

16857

Identifier Type: -

Identifier Source: org_study_id