Phase 1
Completed N=56
A Study of Lasmiditan on the Heart in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT03465436 ↗
Enrolled (actual)
56
Serious AEs
0.5%
Results posted
Jan 2020
Primary outcomePrimary: Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin — -8.90; -9.27; -5.49; 1.90 milliseconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin |
-8.90; -9.27; -5.49; 1.90; -7.42; -4.58 | — |
| SECONDARY Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin |
-9.92; -10.56; -5.27; 2.24; -9.50; -6.90 | — |
| SECONDARY Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin |
74.40; 98.52; 42.13; 18.66; 149.22; 153.15 | — |
| SECONDARY Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin |
0.11; -0.10; 0.09; -0.00; -0.24; 0.45 | — |
| SECONDARY Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin |
-3.90; -5.51; -2.41; -1.02; -7.82; -8.40 | — |
| SECONDARY Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan |
104.55; 526.15 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan |
684.66; 3189.08 | — |
Eligibility 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
- Supine resting heart rate 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
Data sourced from ClinicalTrials.gov (NCT03465436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.