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A Study of Lasmiditan and Propranolol in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270644
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Lasmiditan Drug: Propranolol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Lasmiditan on Heart Rate and Blood Pressure in Healthy Subjects Receiving Oral Doses of Propranolol
Actual Study Start Date : August 31, 2017
Actual Primary Completion Date : November 22, 2017
Actual Study Completion Date : November 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lasmiditan
Single oral dose of lasmiditan on Day 1
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Active Comparator: Propranolol
Twice daily oral doses of propranolol on Days 4-10
Drug: Propranolol
Administered orally

Experimental: Lasmiditan + Propranolol
Single oral dose of lasmiditan + two oral doses of propranolol on Day 9
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Drug: Propranolol
Administered orally




Primary Outcome Measures :
  1. Change from Baseline in Mean Hourly Heart Rate [ Time Frame: Day 8, Day 9 ]
    Change in mean hourly heart rate as determined by Holter ambulatory monitoring


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan, Propranolol, and Lasmiditan + Propranolol [ Time Frame: Baseline up to 48 hours postdose ]
    PK: Cmax of lasmiditan, propranolol, and lasmiditan + propranolol

  2. PK: Area Under the Concentration versus Time Curve (AUC) of Lasmiditan, Propranolol, and Lasmiditan + Propranolol [ Time Frame: Baseline up to 48 hours postdose ]
    PK: AUC of lasmiditan, propranolol, and lasmiditan + propranolol

  3. Change from Baseline in PR Interval [ Time Frame: Day 8, Day 9 ]
    PR interval is the interval between the P wave and the QRS complex calculated from electrocardiogram (ECG) data

  4. Change from Baseline in Systolic Blood Pressure [ Time Frame: Day 8, Day 9 ]
    Change from baseline in systolic blood pressure

  5. Change from Baseline in Diastolic Blood Pressure [ Time Frame: Day 8, Day 9 ]
    Change from baseline in diastolic blood pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270644


Locations
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United States, Florida
Covance Daytona Beach
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03270644     History of Changes
Other Study ID Numbers: 16857
H8H-MC-LAHD ( Other Identifier: Eli Lilly and Company )
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents