A Study of Lasmiditan on the Heart in Healthy Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465436
• Other study ID #: 16900
• Secondary ID: H8H-CD-LAHPCOL-M
• Status: Completed
• Phase: Phase 1
• Start date: September 16, 2011
• Est. completion date: December 20, 2011

Study information

• Verified date: March 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 20, 2011
• Est. primary completion date: December 20, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lasmiditan
100 mg administered orally (PO)
• Lasmiditan
400 mg administered PO
• Placebo
Placebo administered for lasmiditan or moxifloxacin
• Moxifloxacin
400 mg moxifloxacin administered PO

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	CoLucid Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin	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.	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
Secondary	Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin	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.	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
Secondary	Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin	ECGs were used to calculate cardiac intervals. The RR interval is the time between two R waves.	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
Secondary	Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin	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.	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
Secondary	Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin	Heart rate was determined during ambulatory blood pressure monitoring (ABPM).	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
Secondary	Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds	ECGs were assessed for morphology abnormalities or changes in QTcf interval greater than 450 milliseconds by a board-certified cardiologist	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
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.	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
Secondary	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan.	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