A Study of Lasmiditan and Propranolol in Healthy Participants

NCT03270644 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16857H8H-MC-LAHD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Day 8) in Mean Hourly Heart Rate Following Propranolol Administered Alone and When Coadministered With Lasmiditan

  Change from baseline in mean hourly heart rate recorded as beats per minute and collected by Holter ambulatory monitoring in response to propranolol administered alone and in combination with lasmiditan.

  Baseline (Day 8), Day 9

Secondary Outcomes (7)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan Alone and When Coadministered With Propranolol

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.

• Pharmacokinetic: Maximum Observed Drug Concentration (Cmax) of Propranolol Alone and When Coadministered With Lasmiditan

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose

• 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

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.

• Pharmacokinetic: Area Under the Concentration Versus Time Curve (AUC) of Propranolol During One Dosing Interval Alone and When Administered With Lasmiditan

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose

• Change From Baseline (Day 8) in PR Interval Following Propranolol Administered Alone and When Coadministered With Lasmiditan

  Baseline (Day 8), Day 9

Study Arms (3)

Lasmiditan Reference

EXPERIMENTAL

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

Drug: Lasmiditan

Propranolol Reference

ACTIVE COMPARATOR

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

Drug: Propranolol

Lasmiditan + Propranolol Test

EXPERIMENTAL

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

Drug: Lasmiditan; Drug: Propranolol

Interventions

Lasmiditan DRUG

Administered orally

Also known as: LY573144

Lasmiditan + Propranolol Test; Lasmiditan Reference

Propranolol DRUG

Administered orally

Lasmiditan + Propranolol Test; Propranolol Reference

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

lasmiditan; Propranolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 1, 2017
• Study Start: August 31, 2017
• Primary Completion: November 22, 2017
• Study Completion: November 22, 2017
• Last Updated: December 16, 2019
• Results First Posted: December 2, 2019

Record last verified: 2019-12

Locations

US (1)