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Completed

NCT Number: NCT03465436

A Study of Lasmiditan on the Heart in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lasmiditan

Drug

100 mg administered orally (PO)

Other names: LY573144

Placebo

Drug

Placebo administered for lasmiditan or moxifloxacin

moxifloxacin

Drug

400 mg moxifloxacin administered PO

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • CoLucid Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 14, 2018
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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