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A Study of Lasmiditan on the Heart 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: NCT03465436
Recruitment Status : Completed
First Posted : March 14, 2018
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. The study lasted a maximum of 46 days for each participant, not including screening.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Repolarization Duration as Well as Other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) With Those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects
Actual Study Start Date : September 16, 2011
Actual Primary Completion Date : December 20, 2011
Actual Study Completion Date : December 20, 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 100 milligrams (mg) Lasmiditan
A single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods.
Drug: Lasmiditan
100 mg administered orally (PO)
Other Name: LY573144

Experimental: 400 mg Lasmiditan
A single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods.
Drug: Lasmiditan
400 mg administered PO
Other Name: LY573144

Placebo Comparator: Placebo
Placebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods.
Drug: Placebo
Placebo administered for lasmiditan or moxifloxacin

Active Comparator: Moxifloxacin
A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods.
Drug: Moxifloxacin
400 mg moxifloxacin administered PO




Primary Outcome Measures :
  1. Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin [ Time Frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose ]
    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.


Secondary Outcome Measures :
  1. Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin [ Time Frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose ]
    The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for participant pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.

  2. Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin [ Time Frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose ]
    ECGs were used to calculate cardiac intervals. The RR interval is the time between two R waves.

  3. Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin [ Time Frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose ]
    ECGs were used to calculate cardiac intervals. The QRS interval is the time the segment of the ECG that corresponds to depolarization of the ventricles.

  4. Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin [ Time Frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose ]
    Heart rate was determined during ambulatory blood pressure monitoring (ABPM).

  5. Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds [ Time Frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose ]
    ECGs were assessed for morphology abnormalities or changes in QTcf interval greater than 450 milliseconds by a board-certified cardiologist

  6. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan [ Time Frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose ]
    Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.

  7. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan [ Time Frame: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose ]
    Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)
  • In good physical and mental health as determined by the following:

    • Complete medical history
    • Complete physical examination
    • Vital signs including blood pressure (supine and standing), heart rate (supine and standing), respiratory rate, and temperature
    • Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for arrhythmia monitoring
    • Clinical laboratory tests

Exclusion Criteria:

  • Any of the following cardiac abnormalities on safety screening ECG:

    • QTcF interval >430 milliseconds (ms) for males, >450 ms for females
    • Unusual T wave morphology or flattened low voltage T waves
    • PR interval >240 ms or <110 ms
    • Second-degree or third-degree atrioventricular block
    • ECG evidence of complete left or right bundle branch block
    • Intraventricular conduction delay or QRS duration >110 ms
    • Supine resting heart rate <45 beats per minute (bpm) or >90 bpm
    • Pathological Q-waves
    • Evidence of ventricular pre-excitation
  • Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
  • Participants with a family history of Long QT syndrome
  • History of allergic hypersensitivity to lasmiditan or any component of the formulations
  • History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
  • Participants with a history of postural hypotension or fainting
  • Participant is not able to understand and comply with study requirements, instructions and study restrictions

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): NCT03465436


Locations
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Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Berlin, Germany, 14050
Sponsors and Collaborators
Eli Lilly and Company
CoLucid Pharmaceuticals
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: NCT03465436    
Other Study ID Numbers: 16900
H8H-CD-LAHP ( Other Identifier: Eli Lilly and Company )
COL-MIG-105 ( Other Identifier: CoLucid Pharmaceuticals )
2011-003229-88 ( EudraCT Number )
First Posted: March 14, 2018    Key Record Dates
Results First Posted: January 31, 2020
Last Update Posted: January 31, 2020
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Moxifloxacin
Lasmiditan
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents