Healthy
Conditions
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 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.
Interventions
DRUGLasmiditan
100 mg administered orally (PO)
DRUGPlacebo
Placebo administered for lasmiditan or moxifloxacin
DRUGMoxifloxacin
400 mg moxifloxacin administered PO
Sponsors
CoLucid Pharmaceuticals
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 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. |
| Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 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. |
| Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 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). |
| Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 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. |
| 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 | Pharmacokinetics (PK): Maximum Concentration (Cmax) 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 | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan. |
| Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 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 |
Countries
Germany
Participant flow
Pre-assignment details
All randomized participants who received at least 1 dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1 ABDC Day 1 of each treatment period with a washout period of 7-14 days.
A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched | 14 |
| Sequence 2 BCAD Day 1 of each treatment period with a washout period of 7-14 days.
B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) | 14 |
| Sequence 3 CDBA Day 1 of each treatment period with a washout period of 7-14 days.
C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO | 14 |
| Sequence 4 DACB Day 1 of each treatment period with a washout period of 7-14 days.
D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO | 14 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1 | Protocol Violation | 0 | 0 | 1 | 0 |
| Period 2 | Protocol Violation | 0 | 1 | 0 | 0 |
| Period 3 | Protocol Violation | 1 | 1 | 0 | 0 |
| Period 4 | Protocol Violation | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Sequence 1 ABDC | Total | Sequence 4 DACB | Sequence 3 CDBA | Sequence 2 BCAD |
|---|---|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 12.3 | 39.3 years STANDARD_DEVIATION 10.8 | 40.7 years STANDARD_DEVIATION 9.1 | 37.5 years STANDARD_DEVIATION 10.8 | 38.4 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 56 Participants | 14 Participants | 14 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 53 Participants | 13 Participants | 14 Participants | 13 Participants |
| Region of Enrollment Germany | 14 Participants | 56 Participants | 14 Participants | 14 Participants | 14 Participants |
| Sex: Female, Male Female | 9 Participants | 27 Participants | 6 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 29 Participants | 8 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 55 | 0 / 54 | 0 / 52 |
| other Total, other adverse events | 21 / 52 | 33 / 55 | 7 / 54 | 9 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 55 | 0 / 54 | 1 / 52 |
Outcome results
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.
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
Population: All randomized participants who received at least 1 dose of study drug and have evaluable QTcF data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 8 hours postdose | -6.74 milliseconds | Standard Deviation 7.16 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.74 milliseconds | Standard Deviation 7.51 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 4 hours postdose | -2.12 milliseconds | Standard Deviation 6.89 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 30 minutes postdose | -8.90 milliseconds | Standard Deviation 7.2 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 6 hours postdose | -4.33 milliseconds | Standard Deviation 7.32 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -7.63 milliseconds | Standard Deviation 5.98 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 2 hours postdose | -6.96 milliseconds | Standard Deviation 7.08 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 1 hour postdose | -7.42 milliseconds | Standard Deviation 5.83 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 12 hours postdose | -3.73 milliseconds | Standard Deviation 5.72 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -5.26 milliseconds | Standard Deviation 7.36 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 3 hours postdose | -2.81 milliseconds | Standard Deviation 6.95 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -2.39 milliseconds | Standard Deviation 7.63 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 1 hour postdose | -4.58 milliseconds | Standard Deviation 8.13 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 3.5 hours postdose | 3.58 milliseconds | Standard Deviation 6.88 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 2 hours postdose | -1.12 milliseconds | Standard Deviation 8.1 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 6 hours postdose | -0.18 milliseconds | Standard Deviation 7.38 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 8 hours postdose | -1.84 milliseconds | Standard Deviation 7.82 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 4 hours postdose | 4.77 milliseconds | Standard Deviation 7.49 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 30 minutes postdose | -9.27 milliseconds | Standard Deviation 6.29 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 3 hours postdose | 2.06 milliseconds | Standard Deviation 8.18 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 2.5 hours postdose | 0.15 milliseconds | Standard Deviation 8.67 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -3.07 milliseconds | Standard Deviation 7.91 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.38 milliseconds | Standard Deviation 7.06 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 12 hours postdose | -0.41 milliseconds | Standard Deviation 6.99 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 4 hours postdose | -2.34 milliseconds | Standard Deviation 5.65 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 30 minutes postdose | -5.49 milliseconds | Standard Deviation 5.52 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 1 hour postdose | -3.94 milliseconds | Standard Deviation 5.15 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -3.68 milliseconds | Standard Deviation 4.66 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 2 hours postdose | -3.83 milliseconds | Standard Deviation 5.28 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -2.89 milliseconds | Standard Deviation 4.99 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 3 hours postdose | -2.04 milliseconds | Standard Deviation 5.71 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -1.85 milliseconds | Standard Deviation 4.59 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 6 hours postdose | -3.39 milliseconds | Standard Deviation 6.59 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 8 hours postdose | -3.99 milliseconds | Standard Deviation 7.11 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 12 hours postdose | -1.79 milliseconds | Standard Deviation 5.91 |
| Placebo | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.45 milliseconds | Standard Deviation 6.18 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 3 hours postdose | 10.01 milliseconds | Standard Deviation 6.42 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 2.5 hours postdose | 8.12 milliseconds | Standard Deviation 7.15 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 30 minutes postdose | 1.90 milliseconds | Standard Deviation 8.69 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 8 hours postdose | 3.90 milliseconds | Standard Deviation 7.13 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 2 hours postdose | 8.16 milliseconds | Standard Deviation 7.21 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 1.5 hours postdose | 7.63 milliseconds | Standard Deviation 6.32 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 24 hours postdose | 6.61 milliseconds | Standard Deviation 7.91 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 12 hours postdose | 4.63 milliseconds | Standard Deviation 7.12 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 4 hours postdose | 9.39 milliseconds | Standard Deviation 5.85 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 3.5 hours postdose | 10.37 milliseconds | Standard Deviation 7.09 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 1 hour postdose | 8.36 milliseconds | Standard Deviation 6.51 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin | 6 hours postdose | 4.91 milliseconds | Standard Deviation 7.05 |
Comparison: 3.5 hours postdose90% CI: [10.32, 14.05]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [9.83, 13.52]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [6.1, 10.39]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [5.66, 10.07]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [4.32, 8.38]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [3.88, 8.38]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [-5.41, -1.59]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [-5.18, -1.89]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [-5.77, -2.43]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [-5.14, -1.28]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [-4.41, -0.51]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [-2.84, 1.03]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [-2.53, 1.29]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [-1.84, 1.99]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [-3.22, 1.1]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-4.88, -0.57]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-3.77, -0.32]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-1.9, 2.33]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [-5.56, -2.11]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [-2.75, 1.25]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [-1.49, 2.38]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [0.58, 4.58]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [0.73, 4.98]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [1.85, 6.03]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [3.61, 6.95]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [4.99, 8.89]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [0.93, 5.34]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-0.23, 4.4]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-0.57, 3.3]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-2.21, 1.63]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [5.03, 9.6]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [10.47, 14.1]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [9.54, 13]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [9.97, 13.87]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [9.17, 12.79]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [10.1, 13.87]Mixed Models Analysis
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.
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
Population: All randomized participants who received at least 1 dose of study drug and have evaluable QRS data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 8 hours postdose | -0.41 milliseconds | Standard Deviation 1.36 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.33 milliseconds | Standard Deviation 1.22 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 4 hours postdose | -0.54 milliseconds | Standard Deviation 1.03 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 30 minutes postdose | 0.11 milliseconds | Standard Deviation 1.12 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 6 hours postdose | 0.20 milliseconds | Standard Deviation 1.43 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -0.48 milliseconds | Standard Deviation 1.13 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 2 hours postdose | -0.73 milliseconds | Standard Deviation 1.12 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 1 hours postdose | -0.24 milliseconds | Standard Deviation 1.21 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 12 hours postdose | 0.34 milliseconds | Standard Deviation 1.46 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -0.75 milliseconds | Standard Deviation 1.41 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 3 hours postdose | -0.63 milliseconds | Standard Deviation 1.21 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -0.58 milliseconds | Standard Deviation 1 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 1 hours postdose | 0.45 milliseconds | Standard Deviation 1.35 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 3.5 hours postdose | 0.15 milliseconds | Standard Deviation 1.15 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 2 hours postdose | 0.10 milliseconds | Standard Deviation 1.08 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 6 hours postdose | 0.64 milliseconds | Standard Deviation 1.5 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 8 hours postdose | -0.39 milliseconds | Standard Deviation 1.43 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 4 hours postdose | 0.29 milliseconds | Standard Deviation 1.17 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 30 minutes postdose | -0.10 milliseconds | Standard Deviation 1.23 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 3 hours postdose | 0.08 milliseconds | Standard Deviation 1.19 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 2.5 hours postdose | 0.30 milliseconds | Standard Deviation 1.22 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 1.5 hours postdose | 0.19 milliseconds | Standard Deviation 1.24 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 24 hours postdose | -0.07 milliseconds | Standard Deviation 1.22 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 12 hours postdose | 0.24 milliseconds | Standard Deviation 1.67 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 4 hours postdose | -0.20 milliseconds | Standard Deviation 0.95 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 30 minutes postdose | 0.09 milliseconds | Standard Deviation 1.28 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 1 hours postdose | -0.02 milliseconds | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -0.37 milliseconds | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 2 hours postdose | -0.30 milliseconds | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -0.21 milliseconds | Standard Deviation 1.08 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 3 hours postdose | -0.26 milliseconds | Standard Deviation 1.19 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -0.17 milliseconds | Standard Deviation 0.98 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 6 hours postdose | 0.73 milliseconds | Standard Deviation 1.34 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 8 hours postdose | -0.28 milliseconds | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 12 hours postdose | 0.63 milliseconds | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 24 hours postdose | -0.10 milliseconds | Standard Deviation 1.32 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 3 hours postdose | -0.35 milliseconds | Standard Deviation 0.93 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -0.20 milliseconds | Standard Deviation 1.11 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 30 minutes postdose | -0.00 milliseconds | Standard Deviation 0.97 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 8 hours postdose | -0.67 milliseconds | Standard Deviation 1.34 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 2 hours postdose | -0.29 milliseconds | Standard Deviation 1.14 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -0.12 milliseconds | Standard Deviation 1.09 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.09 milliseconds | Standard Deviation 1.28 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 12 hours postdose | 0.32 milliseconds | Standard Deviation 1.52 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 4 hours postdose | -0.58 milliseconds | Standard Deviation 1.25 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -0.57 milliseconds | Standard Deviation 1.34 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 1 hours postdose | -0.12 milliseconds | Standard Deviation 1.07 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin | 6 hours postdose | 0.13 milliseconds | Standard Deviation 1.39 |
Comparison: 30 minutes postdose90% CI: [-0.37, 0.41]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [-0.61, 0.15]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [-0.47, 0.23]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [-0.81, -0.07]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [-0.95, -0.15]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [-0.77, 0]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [-0.72, -0.1]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [-0.66, -0.04]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [-0.98, -0.09]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-0.58, 0.31]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-0.7, 0.12]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [0.01, 0.84]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [-0.59, 0.21]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [0.06, 0.89]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [0.19, 0.93]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [0.02, 0.77]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [0.13, 0.88]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [-0.05, 0.71]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [-0.02, 0.67]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [0.16, 0.84]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [-0.56, 0.36]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-0.56, 0.33]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-0.84, 0.06]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-0.37, 0.45]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [-0.45, 0.28]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [-0.46, 0.27]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [-0.1, 0.6]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [-0.38, 0.4]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [-0.34, 0.37]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [-0.44, 0.25]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [-0.76, -0.03]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [-0.73, -0.03]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [-1.03, -0.17]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-0.82, 0.04]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-0.7, 0.09]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-0.23, 0.61]Mixed Models Analysis
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.
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
Population: All randomized participants who received at least 1 dose of study drug and have evaluable RR interval data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 2 hours postdose | 118.39 milliseconds | Standard Deviation 60.84 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 1 hour postdose | 149.22 milliseconds | Standard Deviation 77.73 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 3.5 hours postdose | 89.85 milliseconds | Standard Deviation 56.54 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 3 hours postdose | 105.56 milliseconds | Standard Deviation 63.82 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 2.5 hours postdose | 117.90 milliseconds | Standard Deviation 73.85 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 24 hours postdose | -16.37 milliseconds | Standard Deviation 68 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 8 hours postdose | 5.63 milliseconds | Standard Deviation 73.58 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 6 hours postdose | -26.01 milliseconds | Standard Deviation 69.03 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 1.5 hours postdose | 143.29 milliseconds | Standard Deviation 80.63 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 12 hours postdose | -26.70 milliseconds | Standard Deviation 77.94 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 30 minutes postdose | 74.40 milliseconds | Standard Deviation 76.26 |
| 100 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 4 hours postdose | 72.22 milliseconds | Standard Deviation 57.19 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 4 hours postdose | 83.00 milliseconds | Standard Deviation 56.84 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 30 minutes postdose | 98.52 milliseconds | Standard Deviation 72.99 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 1 hour postdose | 153.15 milliseconds | Standard Deviation 65.13 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 1.5 hours postdose | 130.79 milliseconds | Standard Deviation 55.91 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 2 hours postdose | 128.10 milliseconds | Standard Deviation 48.5 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 2.5 hours postdose | 132.86 milliseconds | Standard Deviation 54.35 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 3 hours postdose | 119.52 milliseconds | Standard Deviation 60.66 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 3.5 hours postdose | 101.86 milliseconds | Standard Deviation 59.04 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 12 hours postdose | 5.19 milliseconds | Standard Deviation 73.16 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 6 hours postdose | -3.07 milliseconds | Standard Deviation 63.34 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 8 hours postdose | 29.01 milliseconds | Standard Deviation 66.89 |
| 400 mg Lasmiditan | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 24 hours postdose | -5.64 milliseconds | Standard Deviation 63.34 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 4 hours postdose | 30.32 milliseconds | Standard Deviation 51.11 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 1 hour postdose | 49.87 milliseconds | Standard Deviation 62.4 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 24 hours postdose | -11.66 milliseconds | Standard Deviation 60.48 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 8 hours postdose | -50.89 milliseconds | Standard Deviation 75.72 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 3.5 hours postdose | 36.77 milliseconds | Standard Deviation 50.34 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 30 minutes postdose | 42.13 milliseconds | Standard Deviation 56 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 2.5 hours postdose | 29.28 milliseconds | Standard Deviation 51.39 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 1.5 hours postdose | 36.84 milliseconds | Standard Deviation 66.52 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 6 hours postdose | -88.95 milliseconds | Standard Deviation 60.15 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 12 hours postdose | -61.53 milliseconds | Standard Deviation 76.51 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 3 hours postdose | 30.84 milliseconds | Standard Deviation 57.28 |
| Placebo | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 2 hours postdose | 44.69 milliseconds | Standard Deviation 53.7 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 3 hours postdose | 24.87 milliseconds | Standard Deviation 66.41 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 12 hours postdose | -74.80 milliseconds | Standard Deviation 70.71 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 3.5 hours postdose | 19.01 milliseconds | Standard Deviation 65.56 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 1.5 hours postdose | 13.44 milliseconds | Standard Deviation 61.66 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 4 hours postdose | 13.64 milliseconds | Standard Deviation 68.55 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 1 hour postdose | 9.63 milliseconds | Standard Deviation 63.32 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 24 hours postdose | -13.02 milliseconds | Standard Deviation 52.97 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 6 hours postdose | -84.12 milliseconds | Standard Deviation 63.34 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 8 hours postdose | -49.70 milliseconds | Standard Deviation 52.21 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 30 minutes postdose | 18.66 milliseconds | Standard Deviation 61.84 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 2.5 hours postdose | 26.90 milliseconds | Standard Deviation 68.18 |
| Moxifloxacin | Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin | 2 hours postdose | 26.01 milliseconds | Standard Deviation 54.44 |
Comparison: 30 minutes postdose90% CI: [11.5, 54.28]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [77.81, 122.5]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [83.31, 130.91]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [56.32, 92.63]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [68.77, 109.61]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [55.41, 94.55]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [36.03, 69.63]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [24.86, 59.35]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [42.39, 82.83]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [32.49, 79.61]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [11.79, 59.63]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-24.66, 15.47]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [36.72, 76.35]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [83.88, 122.72]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [75.15, 113.26]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [67.98, 99]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [87.28, 120]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [71.24, 107.29]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [48.28, 82.3]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [36.1, 69.6]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [66.36, 105.82]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [58.32, 101.91]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [44.64, 90.51]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-10.01, 25.55]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [-38.44, -5.6]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [-57.15, -20.6]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [-39.35, -4.91]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [-32.15, -2.56]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [-18.17, 16.12]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [-21.81, 12.27]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [-33.36, 0.24]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [-32.94, 2.37]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [-10.86, 23.11]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-15.25, 19.8]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-33.46, 9.56]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-17.32, 16.69]Mixed Models Analysis
Secondary
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
Heart rate was determined during ambulatory blood pressure monitoring (ABPM).
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
Population: All randomized participants who received at least 1 dose of study drug and have evaluable HR data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 8 hours postdose | -0.43 beats per minute | Standard Deviation 4.73 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 24 hours postdose | 1.01 beats per minute | Standard Deviation 4.45 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 4 hours postdose | -4.22 beats per minute | Standard Deviation 3.06 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 30 minutes postdose | -3.90 beats per minute | Standard Deviation 5.05 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 6 hours postdose | 1.65 beats per minute | Standard Deviation 4.52 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -7.55 beats per minute | Standard Deviation 4.16 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 2 hours postdose | -6.62 beats per minute | Standard Deviation 3.22 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 1 hour postdose | -7.82 beats per minute | Standard Deviation 3.95 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 12 hours postdose | 1.58 beats per minute | Standard Deviation 5.31 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -6.49 beats per minute | Standard Deviation 4.07 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 3 hours postdose | -5.96 beats per minute | Standard Deviation 3.32 |
| 100 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -5.26 beats per minute | Standard Deviation 3.02 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 1 hour postdose | -8.40 beats per minute | Standard Deviation 3.21 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -6.02 beats per minute | Standard Deviation 3.5 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 2 hours postdose | -7.30 beats per minute | Standard Deviation 2.93 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 6 hours postdose | -0.10 beats per minute | Standard Deviation 3.77 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 8 hours postdose | -1.96 beats per minute | Standard Deviation 3.93 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 4 hours postdose | -5.02 beats per minute | Standard Deviation 3.42 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 30 minutes postdose | -5.51 beats per minute | Standard Deviation 3.74 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 3 hours postdose | -6.82 beats per minute | Standard Deviation 3.53 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -7.59 beats per minute | Standard Deviation 3.27 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -7.41 beats per minute | Standard Deviation 3.14 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.42 beats per minute | Standard Deviation 4.09 |
| 400 mg Lasmiditan | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 12 hours postdose | -0.50 beats per minute | Standard Deviation 4.66 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 4 hours postdose | -1.82 beats per minute | Standard Deviation 3.19 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 30 minutes postdose | -2.41 beats per minute | Standard Deviation 3.22 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 1 hour postdose | -2.77 beats per minute | Standard Deviation 3.55 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -2.01 beats per minute | Standard Deviation 3.53 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 2 hours postdose | -2.65 beats per minute | Standard Deviation 3.17 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -1.75 beats per minute | Standard Deviation 2.97 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 3 hours postdose | -1.83 beats per minute | Standard Deviation 3.35 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -2.32 beats per minute | Standard Deviation 3.06 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 6 hours postdose | 6.29 beats per minute | Standard Deviation 5.18 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 8 hours postdose | 3.42 beats per minute | Standard Deviation 5.05 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 12 hours postdose | 4.17 beats per minute | Standard Deviation 5.46 |
| Placebo | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.89 beats per minute | Standard Deviation 3.96 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 3 hours postdose | -1.26 beats per minute | Standard Deviation 3.95 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -1.48 beats per minute | Standard Deviation 4.07 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 30 minutes postdose | -1.02 beats per minute | Standard Deviation 3.75 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 8 hours postdose | 3.10 beats per minute | Standard Deviation 3.42 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 2 hours postdose | -1.52 beats per minute | Standard Deviation 3.19 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -0.67 beats per minute | Standard Deviation 3.73 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.81 beats per minute | Standard Deviation 3.6 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 12 hours postdose | 4.95 beats per minute | Standard Deviation 5.12 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 4 hours postdose | -0.55 beats per minute | Standard Deviation 4.37 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -0.91 beats per minute | Standard Deviation 4.23 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 1 hour postdose | -0.42 beats per minute | Standard Deviation 4.05 |
| Moxifloxacin | Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin | 6 hours postdose | 5.84 beats per minute | Standard Deviation 4.84 |
Comparison: 30 minutes postdose90% CI: [-2.9, -0.16]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [-6.29, -3.88]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [-6.81, -4.32]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [-5, -3.01]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [-5.91, -3.65]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [-5.2, -3.08]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [-3.87, -2.01]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [-3.42, -1.42]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [-6.17, -3.06]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-5.38, -2.26]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-4.33, -0.97]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-1.22, 1.46]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [-4.16, -2.02]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [-6.65, -4.58]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [-6.42, -4.35]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [-5.55, -3.72]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [-6.77, -4.87]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [-6.03, -3.96]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [-4.68, -2.71]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [-4.21, -2.17]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [-7.83, -4.95]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-6.73, -4.02]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-6.25, -3.17]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-1.74, 0.63]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [0.32, 2.33]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [1.19, 3.4]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [0.31, 2.28]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [0.17, 1.97]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [-0.81, 1.23]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [-0.5, 1.56]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [0.29, 2.44]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [0.09, 2.34]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [-1.97, 0.99]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-1.54, 0.83]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-0.87, 2.34]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-1.29, 1.04]Mixed Models Analysis
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.
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
Population: All randomized participants who received at least 1 dose of study drug and have evaluable QTcI data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 8 hours postdose | -7.10 milliseconds | Standard Deviation 7.76 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 24 hours postdose | 1.60 milliseconds | Standard Deviation 6.84 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 4 hours postdose | -3.25 milliseconds | Standard Deviation 8.07 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 30 minutes postdose | -9.92 milliseconds | Standard Deviation 7.62 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 6 hours postdose | -4.84 milliseconds | Standard Deviation 7 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -9.39 milliseconds | Standard Deviation 6.93 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 2 hours postdose | -8.74 milliseconds | Standard Deviation 8.34 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 1 hour postdose | -9.50 milliseconds | Standard Deviation 7.74 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 12 hours postdose | -4.08 milliseconds | Standard Deviation 5.88 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -7.90 milliseconds | Standard Deviation 9.42 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 3 hours postdose | -5.08 milliseconds | Standard Deviation 8.29 |
| 100 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -3.86 milliseconds | Standard Deviation 8.72 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 1 hour postdose | -6.90 milliseconds | Standard Deviation 8.98 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 3.5 hours postdose | 1.90 milliseconds | Standard Deviation 7.48 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 2 hours postdose | -2.65 milliseconds | Standard Deviation 8.56 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 6 hours postdose | -1.27 milliseconds | Standard Deviation 6.65 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 8 hours postdose | -3.08 milliseconds | Standard Deviation 8.23 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 4 hours postdose | 3.27 milliseconds | Standard Deviation 8.44 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 30 minutes postdose | -10.56 milliseconds | Standard Deviation 8 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 3 hours postdose | -0.13 milliseconds | Standard Deviation 8.63 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -1.80 milliseconds | Standard Deviation 8.84 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -4.73 milliseconds | Standard Deviation 8.29 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.45 milliseconds | Standard Deviation 6.85 |
| 400 mg Lasmiditan | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 12 hours postdose | -0.64 milliseconds | Standard Deviation 6.86 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 4 hours postdose | -1.19 milliseconds | Standard Deviation 6.37 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 30 minutes postdose | -5.27 milliseconds | Standard Deviation 6.04 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 1 hour postdose | -3.35 milliseconds | Standard Deviation 5.52 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 1.5 hours postdose | -2.81 milliseconds | Standard Deviation 5.58 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 2 hours postdose | -3.49 milliseconds | Standard Deviation 5.82 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 2.5 hours postdose | -2.44 milliseconds | Standard Deviation 5.61 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 3 hours postdose | -1.70 milliseconds | Standard Deviation 6.1 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 3.5 hours postdose | -1.67 milliseconds | Standard Deviation 5.01 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 6 hours postdose | -3.13 milliseconds | Standard Deviation 6.61 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 8 hours postdose | -3.89 milliseconds | Standard Deviation 6.77 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 12 hours postdose | -1.65 milliseconds | Standard Deviation 6.09 |
| Placebo | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 24 hours postdose | 0.81 milliseconds | Standard Deviation 6.22 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 3 hours postdose | 11.01 milliseconds | Standard Deviation 6.89 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 2.5 hours postdose | 8.40 milliseconds | Standard Deviation 7.53 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 30 minutes postdose | 2.24 milliseconds | Standard Deviation 8.88 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 8 hours postdose | 4.04 milliseconds | Standard Deviation 7.01 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 2 hours postdose | 8.29 milliseconds | Standard Deviation 7.03 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 1.5 hours postdose | 8.61 milliseconds | Standard Deviation 6.42 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 24 hours postdose | 6.74 milliseconds | Standard Deviation 8.14 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 12 hours postdose | 4.87 milliseconds | Standard Deviation 7.14 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 4 hours postdose | 10.28 milliseconds | Standard Deviation 6.5 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 3.5 hours postdose | 11.43 milliseconds | Standard Deviation 7.38 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 1 hour postdose | 8.96 milliseconds | Standard Deviation 7.14 |
| Moxifloxacin | Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin | 6 hours postdose | 4.85 milliseconds | Standard Deviation 7.37 |
Comparison: 2 hours postdose90% CI: [-6.64, -2.3]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [-6.87, -2.19]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [-4.9, -0.59]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [-3.86, 0.39]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [-3.77, 0.44]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [-3.17, 0.94]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-4.58, -0.35]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-3.87, -0.43]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-1.14, 2.72]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [-6.47, -2.52]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [-7.18, -3.42]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [-7.57, -3.82]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [-6.57, -2.71]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [-4.59, -0.39]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [-3.02, 1.09]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [-0.46, 3.73]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [-0.59, 3.81]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [0.25, 4.57]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [2.48, 6.12]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [3.02, 7.27]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [0.75, 4.79]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [-0.55, 4.05]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [-0.19, 3.69]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [-2.44, 1.48]Mixed Models Analysis
Comparison: 30 minutes postdose90% CI: [4.72, 9.41]Mixed Models Analysis
Comparison: 1 hour postdose90% CI: [9.94, 13.69]Mixed Models Analysis
Comparison: 1.5 hours postdose90% CI: [9.16, 12.74]Mixed Models Analysis
Comparison: 2 hours postdose90% CI: [9.5, 13.43]Mixed Models Analysis
Comparison: 2.5 hours postdose90% CI: [8.9, 12.71]Mixed Models Analysis
Comparison: 3 hours postdose90% CI: [10.42, 14.28]Mixed Models Analysis
Comparison: 3.5 hours postdose90% CI: [10.76, 14.54]Mixed Models Analysis
Comparison: 4 hours postdose90% CI: [9.23, 13.1]Mixed Models Analysis
Comparison: 6 hours postdose90% CI: [6.02, 10.22]Mixed Models Analysis
Comparison: 8 hours postdose90% CI: [6.01, 10.19]Mixed Models Analysis
Comparison: 12 hours postdose90% CI: [4.23, 8.28]Mixed Models Analysis
Comparison: 24 hours postdose90% CI: [3.47, 8.01]Mixed Models Analysis
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
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
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 3 hours postdose | 1 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 30 minutes postdose | 0 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 6 hours postdose | 0 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 3.5 hours postdose | 1 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 4 hours postdose | 1 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | Predose | 0 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 24 hours postdose | 0 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 1 hour postdose | 2 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 12 hours postdose | 0 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 1.5 hours postdose | 0 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 2 hours postdose | 1 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 8 hours postdose | 0 Incidents |
| 100 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 2.5 hours postdose | 1 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 3 hours postdose | 1 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 2.5 hours postdose | 1 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 1.5 hours postdose | 1 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | Predose | 0 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 3.5 hours postdose | 2 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 30 minutes postdose | 0 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 4 hours postdose | 1 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 8 hours postdose | 1 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 2 hours postdose | 1 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 24 hours postdose | 0 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 6 hours postdose | 0 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 1 hour postdose | 0 Incidents |
| 400 mg Lasmiditan | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 12 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 1 hour postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | Predose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 30 minutes postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 1.5 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 2 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 2.5 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 3 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 3.5 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 4 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 6 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 8 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 12 hours postdose | 0 Incidents |
| Placebo | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 24 hours postdose | 0 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 30 minutes postdose | 1 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 6 hours postdose | 0 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 2 hours postdose | 3 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 1.5 hours postdose | 2 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | Predose | 0 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 1 hour postdose | 2 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 8 hours postdose | 0 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 24 hours postdose | 0 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 3.5 hours postdose | 3 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 12 hours postdose | 0 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 4 hours postdose | 3 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 3 hours postdose | 2 Incidents |
| Moxifloxacin | Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds | 2.5 hours postdose | 2 Incidents |
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.
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
Population: All randomized participants who received at least 1 dose of lasmiditan.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 100 mg Lasmiditan | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan | 684.66 hours*nanogram per milliliter | Geometric Coefficient of Variation 278.258 |
| 400 mg Lasmiditan | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan | 3189.08 hours*nanogram per milliliter | Geometric Coefficient of Variation 1152.338 |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
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
Population: All randomized participants who received at least 1 dose of lasmiditan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 100 mg Lasmiditan | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | 104.55 nanogram per milliliter | Standard Deviation 41.452 |
| 400 mg Lasmiditan | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | 526.15 nanogram per milliliter | Standard Deviation 240.997 |