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A Study of Lasmiditan When Given With Sumatriptan 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: NCT03310411
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The purpose of this study is to assess whether taking lasmiditan and sumatriptan together will have any additional effects on heart rate and blood pressure compared to taking lasmiditan and sumatriptan individually. This study will also look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it when these two drugs are taken together.

This study will last about 21 days, not including the screening. Participants will spend 16 days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is required within 28 days prior to the start of the study.


Condition or disease Intervention/treatment Phase
Healthy Drug: Lasmiditan Drug: Sumatriptan Drug: Placebo for Lasmiditan Drug: Placebo for Sumatriptan Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Four-Period, Crossover Study to Evaluate the Cardiovascular Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Subjects
Actual Study Start Date : October 17, 2017
Actual Primary Completion Date : December 23, 2017
Actual Study Completion Date : December 23, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sumatriptan

Arm Intervention/treatment
Experimental: Lasmiditan + Sumatriptan (A)
Single oral dose of lasmiditan and single oral dose of sumatriptan in one of four treatment periods.
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Drug: Sumatriptan
Administered orally

Experimental: Lasmiditan + Placebo (B)
Single oral dose of lasmiditan and single oral dose of placebo in one of four treatment periods.
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Drug: Placebo for Sumatriptan
Administered orally

Active Comparator: Sumatriptan + Placebo (C)
Single oral dose of sumatriptan and single oral dose of placebo in one of four treatment periods.
Drug: Sumatriptan
Administered orally

Drug: Placebo for Lasmiditan
Administered orally

Placebo Comparator: Placebo + Placebo (D)
Oral doses of placebo in one of four treatment periods.
Drug: Placebo for Lasmiditan
Administered orally

Drug: Placebo for Sumatriptan
Administered orally




Primary Outcome Measures :
  1. Pharmacodynamics (PD): Systolic Blood Pressure (SBP) [ Time Frame: Baseline through 24 hours after administration of study drug in each period ]
    Systolic Blood Pressure (SBP) per 24-hour Ambulatory Blood Pressure Monitoring (ABPM)


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan, Sumatriptan, and Lasmiditan + Sumatriptan [ Time Frame: Baseline through 48 hours after administration of study drug in each period ]
    PK: Cmax of Lasmiditan, Sumatriptan, and Lasmiditan + Sumatriptan

  2. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0 ∞]) of Lasmiditan, Sumatriptan, and Lasmiditan + Sumatriptan [ Time Frame: Baseline through 48 hours after administration of study drug in each period ]
    PK: AUC(0 ∞) of Lasmiditan, Sumatriptan and Lasmiditan + Sumatriptan



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:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria:

  • Have known allergies to Lasmiditan, Sumatriptan, related compounds, or any components of the formulations of Lasmiditan and Sumatriptan
  • Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias
  • Have a history, signs, or symptoms of arrhythmia or Wolff Parkinson White syndrome that could affect the participant's safety
  • Have an estimated glomerular filtration rate (eGFR) of less than (<) 60 milliliter per minute (mL/min) per 1.73 m²
  • Have a resting systolic blood pressure (SBP) greater than (>) 135 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) >85 mmHg at screening
  • Have a supine pulse rate (PR) of <50 or >90 beats per minute (bpm) at screening
  • Have a history, signs, or symptoms of vasospastic coronary artery disease
  • Have known or ongoing neuropsychiatric disorders (for example, manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator
  • Use of monoamine oxidase-A inhibitors and other drugs associated with serotonin within the 3 months prior to the first dosing occasion

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): NCT03310411


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: NCT03310411     History of Changes
Other Study ID Numbers: 16926
H8H-MC-LAHU ( Other Identifier: Eli Lilly and Company )
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

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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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Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs