Overview
A Study of Lasmiditan on the Heart in Healthy Participants
Status:
Completed
Completed
Trial end date:
2011-12-20
2011-12-20
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Eli Lilly and CompanyCollaborator:
CoLucid PharmaceuticalsTreatments:
Fluoroquinolones
Lasmiditan
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
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