Status:
COMPLETED
A Study of Lasmiditan on the Heart in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
CoLucid Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03465436
Start Date
September 16 2011
End Date
December 20 2011
Last Update
January 31 2020
Active Locations (1)
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1
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