Trial Outcomes & Findings for A Study of Lasmiditan in Healthy Participants (NCT NCT03182920)
NCT ID: NCT03182920
Last Updated: 2020-01-07
Results Overview
Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours
Results posted on
2020-01-07
Participant Flow
Participant milestones
| Measure |
Sequence 1: Group 1 Elderly
Placebo on day 1 of period 1 200 mg of lasmiditan on Day 1 of period 2.
|
Sequence 2: Group 1 Elderly
200 mg of lasmiditan on Day 1 of period 1. Placebo on Day 1 of period 2.
|
200 mg Lasmiditan (Group 2 Young)
200 mg of lasmiditan on Day 1.
|
|---|---|---|---|
|
Period 1
STARTED
|
9
|
9
|
17
|
|
Period 1
COMPLETED
|
9
|
9
|
17
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period
STARTED
|
9
|
9
|
0
|
|
Washout Period
COMPLETED
|
9
|
9
|
0
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2
STARTED
|
9
|
9
|
0
|
|
Period 2
COMPLETED
|
9
|
9
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Lasmiditan in Healthy Participants
Baseline characteristics by cohort
| Measure |
Group 1 Elderly
n=18 Participants
Placebo on Day 1 of 1 of 2 dosing periods or 200 milligrams (mg) lasmiditan on Day 1 of 1 of 2 dosing periods.
|
200 mg Lasmiditan (Group 2 Young)
n=17 Participants
200 mg of lasmiditan on Day 1.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 5.4 • n=39 Participants
|
31.3 years
STANDARD_DEVIATION 7.7 • n=41 Participants
|
51.5 years
STANDARD_DEVIATION 21.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hoursPopulation: All participants who received at least one dose of study drug.
Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Outcome measures
| Measure |
200 mg Lasmiditan (Group 1 Elderly)
n=18 Participants
200 mg lasmiditan on Day 1 of 1 of 2 dosing periods.
|
200 mg Lasmiditan (Group 2 Young)
n=17 Participants
200 mg of lasmiditan on Day 1.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
|
368 Nanograms Per Millilitre (ng/mL)
Geometric Coefficient of Variation 43
|
304 Nanograms Per Millilitre (ng/mL)
Geometric Coefficient of Variation 40
|
PRIMARY outcome
Timeframe: Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hoursPopulation: All participants who received at least one dose of study drug.
Area under the concentration versus time curve from zero to infinity
Outcome measures
| Measure |
200 mg Lasmiditan (Group 1 Elderly)
n=18 Participants
200 mg lasmiditan on Day 1 of 1 of 2 dosing periods.
|
200 mg Lasmiditan (Group 2 Young)
n=17 Participants
200 mg of lasmiditan on Day 1.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan
|
2480 Nanograms*hour per Millilitre (ng.h/mL)
Geometric Coefficient of Variation 44
|
1970 Nanograms*hour per Millilitre (ng.h/mL)
Geometric Coefficient of Variation 30
|
Adverse Events
Placebo (Group 1 Elderly)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg Lasmiditan (Group 1 Elderly)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
200 mg Lasmiditan (Group 2 Young)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Group 1 Elderly)
n=18 participants at risk
Placebo on Day 1 of 1 of 2 dosing periods.
|
200 mg Lasmiditan (Group 1 Elderly)
n=18 participants at risk
200 mg lasmiditan on Day 1 of 1 of 2 dosing periods.
|
200 mg Lasmiditan (Group 2 Young)
n=17 participants at risk
200 mg of lasmiditan on Day 1.
|
|---|---|---|---|
|
Eye disorders
Photopsia
|
0.00%
0/18 • Up to 10 Days
|
11.1%
2/18 • Number of events 2 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/18 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/18 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
General disorders
Fatigue
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
General disorders
Sensation of foreign body
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/18 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • Up to 10 Days
|
11.1%
2/18 • Number of events 2 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Nervous system disorders
Ataxia
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Up to 10 Days
|
33.3%
6/18 • Number of events 6 • Up to 10 Days
|
23.5%
4/17 • Number of events 4 • Up to 10 Days
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
11.1%
2/18 • Number of events 2 • Up to 10 Days
|
11.8%
2/17 • Number of events 2 • Up to 10 Days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • Up to 10 Days
|
11.1%
2/18 • Number of events 2 • Up to 10 Days
|
11.8%
2/17 • Number of events 2 • Up to 10 Days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
17.6%
3/17 • Number of events 3 • Up to 10 Days
|
|
Nervous system disorders
Tremor
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/18 • Up to 10 Days
|
0.00%
0/18 • Up to 10 Days
|
5.9%
1/17 • Number of events 1 • Up to 10 Days
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/18 • Up to 10 Days
|
5.6%
1/18 • Number of events 1 • Up to 10 Days
|
0.00%
0/17 • Up to 10 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60