Trial Outcomes & Findings for A Study of Multiple Doses of Lasmiditan in Healthy Participants (NCT NCT03252015)
NCT ID: NCT03252015
Last Updated: 2020-01-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
70 participants
Primary outcome timeframe
Baseline through 14 days after last administration of study drug
Results posted on
2020-01-10
Participant Flow
Participant milestones
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
28
|
15
|
15
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
12
|
28
|
15
|
15
|
|
Overall Study
COMPLETED
|
11
|
27
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Days -3 and Day 7.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Multiple Doses of Lasmiditan in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=12 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=28 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
n=15 Participants
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
n=15 Participants
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
40.9 years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Weight
|
74.78 kilograms (kg)
STANDARD_DEVIATION 13.14 • n=5 Participants
|
81.92 kilograms (kg)
STANDARD_DEVIATION 13.72 • n=7 Participants
|
74.13 kilograms (kg)
STANDARD_DEVIATION 11.04 • n=5 Participants
|
78.95 kilograms (kg)
STANDARD_DEVIATION 14.67 • n=4 Participants
|
78.39 kilograms (kg)
STANDARD_DEVIATION 13.45 • n=21 Participants
|
|
Body Mass Index (BMI)
|
27.17 kilograms per meter squared
STANDARD_DEVIATION 2.54 • n=5 Participants
|
28.18 kilograms per meter squared
STANDARD_DEVIATION 3.51 • n=7 Participants
|
25.87 kilograms per meter squared
STANDARD_DEVIATION 3.32 • n=5 Participants
|
27.14 kilograms per meter squared
STANDARD_DEVIATION 3.88 • n=4 Participants
|
27.29 kilograms per meter squared
STANDARD_DEVIATION 3.45 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through 14 days after last administration of study drugPopulation: All participants who received at least 1 dose 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.
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=12 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=28 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
n=15 Participants
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
n=15 Participants
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdosePopulation: All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.
PK: Cmax of lasmiditan
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=28 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=15 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1
|
349 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
750 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
—
|
—
|
SECONDARY outcome
Timeframe: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdosePopulation: All participants who received at least 1 dose of lasmiditan on Day 7 and had evaluable PK data.
PK: Cmax of lasmiditan Day 7
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=26 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=14 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7
|
353 ng/mL
Geometric Coefficient of Variation 29
|
808 ng/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdosePopulation: All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.
PK: AUCtau of lasmiditan
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=28 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=15 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
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
|
4530 nanograms times hour per milliLiter
Geometric Coefficient of Variation 39
|
—
|
—
|
SECONDARY outcome
Timeframe: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdosePopulation: All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.
PK AUCtau of lasmiditan
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=26 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=14 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
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
|
4690 nanograms time hours per milliLiter
Geometric Coefficient of Variation 36
|
—
|
—
|
SECONDARY outcome
Timeframe: PreDose Day 7 and Day 21Population: All participants who received at least 1 dose of study drug and completed the questionnaire.
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.
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=12 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=28 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
n=15 Participants
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
n=15 Participants
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score
Day 7
|
0.0 units on a scale
Standard Deviation 0.0
|
0.2 units on a scale
Standard Deviation 0.6
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.3
|
|
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score
Day 21
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Day 7 and Day 21 at anytimePopulation: All participants who received at least 1 dose of study drug and had completed the questionnaire.
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.
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=12 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=28 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
n=15 Participants
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
n=14 Participants
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Physician Withdrawal Checklist (PWC)Total Score
Day 7 Predose
|
0.2 units on a scale
Standard Deviation 0.4
|
0.0 units on a scale
Standard Deviation 0.2
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.3
|
|
Physician Withdrawal Checklist (PWC)Total Score
Day 21
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.4
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdosePopulation: All participant who received at least 1 dose of lasmiditan and had evaluable PK data.
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.
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=28 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=15 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1
|
407 mg/mL
Geometric Coefficient of Variation 24
|
964 mg/mL
Geometric Coefficient of Variation 18
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdosePopulation: All participants who received at least one dose of lasmiditan and had evaluable PK data.
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.
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=26 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=14 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7
|
641 ng/mL
Geometric Coefficient of Variation 20
|
1500 ng/mL
Geometric Coefficient of Variation 20
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
PK: Cmax of midazolam.
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=40 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
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.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam
|
10. nanograms per milliLiter
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdosePopulation: All randomized participant who received midazolam on Day 7 and had evaluable PK parameters.
PK of midazolam.
Outcome measures
| Measure |
Cohort 1a (Placebo+Probe Drug Cocktail)
n=11 Participants
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
n=27 Participants
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Cohort 2a (Placebo)
Placebo administered daily PO, Days 1-7.
|
Cohort 2b (400 mg Lasmiditan)
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7
|
10.1 nanograms per milliliter
Geometric Coefficient of Variation 40
|
9.45 nanograms per milliliter
Geometric Coefficient of Variation 34
|
—
|
—
|
Adverse Events
Probe Drug Cocktail (Cohort 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 mg Lasmiditan QD (Cohort 1)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
200 mg Lasmiditan QD + Probe Drug Cocktail (Cohort 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo QD (Cohort 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo QD + Probe Drug Cocktail (Cohort 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
400 mg Lasmiditan QD (Cohort 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo QD (Cohort 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Probe Drug Cocktail (Cohort 1)
n=40 participants at risk
Probe drug cocktail administered on Day 13 and Day 7
|
200 mg Lasmiditan QD (Cohort 1)
n=28 participants at risk
Daily,oral (PO), 200 mg lasmiditan Days 1-6
|
200 mg Lasmiditan QD + Probe Drug Cocktail (Cohort 1)
n=27 participants at risk
Daily,oral (PO), 200 mg lasmiditan Days 1-6 and concurrently with probe drug cocktail on Day 7.
|
Placebo QD (Cohort 1)
n=12 participants at risk
Placebo administered daily PO, Days 1-7
|
Placebo QD + Probe Drug Cocktail (Cohort 1)
n=11 participants at risk
Placebo administered alone, orally (PO), on Days 1-6 and concurrently with probe drug cocktail on Day -3 and Day 7
|
400 mg Lasmiditan QD (Cohort 2)
n=15 participants at risk
Daily,oral (PO), 400 mg lasmiditan Days 1-7
|
Placebo QD (Cohort 2)
n=15 participants at risk
Placebo administered daily PO, Days 1-7
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Number of events 5 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrong technique in product usage process
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Number of events 8 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
20.0%
3/15 • Number of events 7 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Number of events 2 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Number of events 2 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/40 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/11 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
0.00%
0/15 • Baseline through 28 days
All participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place