Healthy
Conditions
Brief summary
The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it. When drugs are taken together, one or all of the drugs used in combination may be affected. This study will also evaluate the concentrations in the blood of a probe drug cocktail taken alone and in combination with lasmiditan. Information about any side effects that may occur will also be collected. The study has two parts. Participants will only enroll in one part. This study will last about 25 days for group 1 and 22 days for group 2, not including screening. Screening is required within 28 days prior to the start of the study. This study is for research purposes only and is not intended to treat any medical condition.
Interventions
Administered orally
DRUGLasmiditan
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females, as determined by medical history and physical examination * Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening
Exclusion criteria
* Have participated, within the last 30 days, in a clinical study involving an Investigational Product (IP) * Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan * Have clinically significant abnormality in the 12-lead ECG, including corrected QT interval (QTc) with Fridericia's correction (QTcF) greater than (\>) 450 milliseconds (ms) for men or \>470 ms for women or any abnormality that in the opinion of the investigator increases the risk of participating in the study (not limited to significant bradycardia or heart block) * History of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression), have a recent history of a suicide attempt (30 days within screening visit and any time between screening visit and baseline); or are clinically judged by the investigator to be at risk for suicide * History of hypoglycemia * Known history of glucose-6-phosphate dehydrogenase deficiency * Are taking a concomitant medication or a dietary substance that affects cytochrome P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through 14 days after last administration of study drug | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7 | Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose | PK: Cmax of lasmiditan Day 7 |
| Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1 | Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose | PK: AUCtau of lasmiditan |
| Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7 | Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose | PK AUCtau of lasmiditan |
| Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | PreDose Day 7 and Day 21 | BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort. |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1 | Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose | PK: Cmax of lasmiditan |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1 | Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose | Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan. |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7 | Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose | Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan. |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam | Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose, | PK: Cmax of midazolam. |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7 | Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose | PK of midazolam. |
| Physician Withdrawal Checklist (PWC)Total Score | Day 7 and Day 21 at anytime | Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. | 12 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7. | 28 |
| Cohort 2a (Placebo) Placebo administered daily PO, Days 1-7. | 15 |
| Cohort 2b (400 mg Lasmiditan) Daily,oral (PO), 400 mg lasmiditan Days 1-7 | 15 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1a (Placebo+Probe Drug Cocktail) | Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Cohort 2a (Placebo) | Cohort 2b (400 mg Lasmiditan) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 11.9 | 42.9 years STANDARD_DEVIATION 12.3 | 39.5 years STANDARD_DEVIATION 11.4 | 36.9 years STANDARD_DEVIATION 9.7 | 40.9 years STANDARD_DEVIATION 11.5 |
| Body Mass Index (BMI) | 27.17 kilograms per meter squared STANDARD_DEVIATION 2.54 | 28.18 kilograms per meter squared STANDARD_DEVIATION 3.51 | 25.87 kilograms per meter squared STANDARD_DEVIATION 3.32 | 27.14 kilograms per meter squared STANDARD_DEVIATION 3.88 | 27.29 kilograms per meter squared STANDARD_DEVIATION 3.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 10 Participants | 5 Participants | 8 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 18 Participants | 10 Participants | 7 Participants | 39 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 | 4 Participants | 13 Participants | 7 Participants | 7 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 15 Participants | 8 Participants | 7 Participants | 38 Participants |
| Region of Enrollment United States | 12 Participants | 28 Participants | 15 Participants | 15 Participants | 70 Participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants | 6 Participants | 30 Participants |
| Sex: Female, Male Male | 6 Participants | 16 Participants | 9 Participants | 9 Participants | 40 Participants |
| Weight | 74.78 kilograms (kg) STANDARD_DEVIATION 13.14 | 81.92 kilograms (kg) STANDARD_DEVIATION 13.72 | 74.13 kilograms (kg) STANDARD_DEVIATION 11.04 | 78.95 kilograms (kg) STANDARD_DEVIATION 14.67 | 78.39 kilograms (kg) STANDARD_DEVIATION 13.45 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 28 | 0 / 27 | 0 / 12 | 0 / 11 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 40 | 13 / 28 | 4 / 27 | 5 / 12 | 1 / 11 | 5 / 15 | 4 / 15 |
| serious Total, serious adverse events | 0 / 40 | 0 / 28 | 0 / 27 | 0 / 12 | 0 / 11 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.
Time frame: Baseline through 14 days after last administration of study drug
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Cohort 2a (Placebo) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Cohort 2b (400 mg Lasmiditan) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
Secondary
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score
BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.
Time frame: PreDose Day 7 and Day 21
Population: All participants who received at least 1 dose of study drug and completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | Day 7 | 0.0 units on a scale | Standard Deviation 0 |
| Cohort 1a (Placebo+Probe Drug Cocktail) | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | Day 21 | 0.0 units on a scale | Standard Deviation 0 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | Day 21 | 0.0 units on a scale | Standard Deviation 0 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | Day 7 | 0.2 units on a scale | Standard Deviation 0.6 |
| Cohort 2a (Placebo) | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | Day 7 | 0.0 units on a scale | Standard Deviation 0 |
| Cohort 2a (Placebo) | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | Day 21 | 0.0 units on a scale | Standard Deviation 0 |
| Cohort 2b (400 mg Lasmiditan) | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | Day 7 | 0.1 units on a scale | Standard Deviation 0.3 |
| Cohort 2b (400 mg Lasmiditan) | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score | Day 21 | 0.0 units on a scale | Standard Deviation 0 |
Comparison: Day 795% CI: [-0.412, 0.049]
Comparison: Day 795% CI: [-0.081, 0.224]
Comparison: Day 2195% CI: [0, 0]
Comparison: Day 2195% CI: [0, 0]
Secondary
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1
PK: AUCtau of lasmiditan
Time frame: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose
Population: All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1 | 2070 nanograms times hour per milliLiter | Geometric Coefficient of Variation 32 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1 | 4530 nanograms times hour per milliLiter | Geometric Coefficient of Variation 39 |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7
PK AUCtau of lasmiditan
Time frame: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose
Population: All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7 | 2160 nanograms time hours per milliLiter | Geometric Coefficient of Variation 29 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7 | 4690 nanograms time hours per milliLiter | Geometric Coefficient of Variation 36 |
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1
PK: Cmax of lasmiditan
Time frame: Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose
Population: All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1 | 349 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 32 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1 | 750 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 44 |
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7
PK: Cmax of lasmiditan Day 7
Time frame: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose
Population: All participants who received at least 1 dose of lasmiditan on Day 7 and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7 | 353 ng/mL | Geometric Coefficient of Variation 29 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7 | 808 ng/mL | Geometric Coefficient of Variation 41 |
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1
Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.
Time frame: Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose
Population: All participant who received at least 1 dose of lasmiditan and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1 | 407 mg/mL | Geometric Coefficient of Variation 24 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1 | 964 mg/mL | Geometric Coefficient of Variation 18 |
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7
Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.
Time frame: Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose
Population: All participants who received at least one dose of lasmiditan and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7 | 641 ng/mL | Geometric Coefficient of Variation 20 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7 | 1500 ng/mL | Geometric Coefficient of Variation 20 |
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam
PK: Cmax of midazolam.
Time frame: Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,
Population: All randomized participant who received midazolam on Day -3 and had evaluable PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam | 10. nanograms per milliLiter | Geometric Coefficient of Variation 39 |
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7
PK of midazolam.
Time frame: Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose
Population: All randomized participant who received midazolam on Day 7 and had evaluable PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7 | 10.1 nanograms per milliliter | Geometric Coefficient of Variation 40 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7 | 9.45 nanograms per milliliter | Geometric Coefficient of Variation 34 |
Secondary
Physician Withdrawal Checklist (PWC)Total Score
Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Time frame: Day 7 and Day 21 at anytime
Population: All participants who received at least 1 dose of study drug and had completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a (Placebo+Probe Drug Cocktail) | Physician Withdrawal Checklist (PWC)Total Score | Day 7 Predose | 0.2 units on a scale | Standard Deviation 0.4 |
| Cohort 1a (Placebo+Probe Drug Cocktail) | Physician Withdrawal Checklist (PWC)Total Score | Day 21 | 0.0 units on a scale | Standard Deviation 0 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Physician Withdrawal Checklist (PWC)Total Score | Day 21 | 0.1 units on a scale | Standard Deviation 0.4 |
| Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) | Physician Withdrawal Checklist (PWC)Total Score | Day 7 Predose | 0.0 units on a scale | Standard Deviation 0.2 |
| Cohort 2a (Placebo) | Physician Withdrawal Checklist (PWC)Total Score | Day 21 | 0.0 units on a scale | Standard Deviation 0 |
| Cohort 2a (Placebo) | Physician Withdrawal Checklist (PWC)Total Score | Day 7 Predose | 0.0 units on a scale | Standard Deviation 0 |
| Cohort 2b (400 mg Lasmiditan) | Physician Withdrawal Checklist (PWC)Total Score | Day 7 Predose | 0.1 units on a scale | Standard Deviation 0.3 |
| Cohort 2b (400 mg Lasmiditan) | Physician Withdrawal Checklist (PWC)Total Score | Day 21 | 0.0 units on a scale | Standard Deviation 0 |
Comparison: Day 795% CI: [-0.34, 0.05]
95% CI: [-0.081, 0.224]
Comparison: Day 2195% CI: [-0.151, 0.294]
Comparison: Day 2195% CI: [0, 0]