Trial Outcomes & Findings for A Study of Lasmiditan in Healthy Elderly Participants (NCT NCT03406260)
NCT ID: NCT03406260
Last Updated: 2019-12-02
Results Overview
Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using linear mixed effects model adjusting for baseline, treatment, treatment sequence, period, treatment by time point interaction, and a random effect of participant.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Baseline through 24 hours after each administration of study drug
Results posted on
2019-12-02
Participant Flow
Crossover study with three study periods, each participant received single oral doses of Lasmiditan 200 milligrams (mg), Lasmiditan 100 mg and Placebo tablets as per the dosing sequence in each period. The washout period between dosing in consecutive study periods was at least 48 hours.
Participant milestones
| Measure |
Sequence 1
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg and Period 3: Placebo
|
Sequence 2
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Placebo and Period 3: Lasmiditan 200 mg
|
Sequence 3
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Placebo, Period 2: Lasmiditan 200 mg and Period 3: Lasmiditan 100 mg
|
Sequence 4
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Placebo, Period 2: Lasmiditan 100 mg and Period 3: Lasmiditan 200 mg
|
Sequence 5
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Placebo and Period 3: Lasmiditan 100 mg
|
Sequence 6
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg and Period 3: Placebo
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Period 3
COMPLETED
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg and Period 3: Placebo
|
Sequence 2
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Placebo and Period 3: Lasmiditan 200 mg
|
Sequence 3
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Placebo, Period 2: Lasmiditan 200 mg and Period 3: Lasmiditan 100 mg
|
Sequence 4
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Placebo, Period 2: Lasmiditan 100 mg and Period 3: Lasmiditan 200 mg
|
Sequence 5
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Placebo and Period 3: Lasmiditan 100 mg
|
Sequence 6
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg and Period 3: Placebo
|
|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Lasmiditan in Healthy Elderly Participants
Baseline characteristics by cohort
| Measure |
Sequence 1
n=6 Participants
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg and Period 3: Placebo
|
Sequence 2
n=6 Participants
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Placebo and Period 3: Lasmiditan 200 mg
|
Sequence 3
n=6 Participants
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Placebo, Period 2: Lasmiditan 200 mg and Period 3: Lasmiditan 100 mg
|
Sequence 4
n=6 Participants
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Placebo, Period 2: Lasmiditan 100 mg and Period 3: Lasmiditan 200 mg
|
Sequence 5
n=6 Participants
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Placebo and Period 3: Lasmiditan 100 mg
|
Sequence 6
n=6 Participants
Participants received Lasmiditan (200 milligrams (mg) and 100mg) and placebo tablets as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg and Period 3: Placebo
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through 24 hours after each administration of study drugPopulation: All randomized participants who received at least one dose of study drug and have data for SBP
Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using linear mixed effects model adjusting for baseline, treatment, treatment sequence, period, treatment by time point interaction, and a random effect of participant.
Outcome measures
| Measure |
Lasmiditan 200 mg
n=36 Participants
Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 (milliliters) mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
Lasmiditan 100 mg
n=34 Participants
Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
Placebo
n=35 Participants
Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
|---|---|---|---|
|
Pharmacodynamics: Change From Baseline in Peak Hourly Mean Values of Systolic Blood Pressure (SBP)
|
15.79 millimeters of mercury (mmHg)
Standard Error 1.774
|
15.50 millimeters of mercury (mmHg)
Standard Error 1.820
|
17.14 millimeters of mercury (mmHg)
Standard Error 1.797
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdosePopulation: All randomized participants who received at least one dose of study drug and have evaluable pharmacokinetics (PK) data.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.
Outcome measures
| Measure |
Lasmiditan 200 mg
n=35 Participants
Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 (milliliters) mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
Lasmiditan 100 mg
n=36 Participants
Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
Placebo
Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
|
159 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
339 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdosePopulation: All randomized participants who received at least one dose of study drug and have evaluable PK data.
PK: Area under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of Lasmiditan.
Outcome measures
| Measure |
Lasmiditan 200 mg
n=35 Participants
Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 (milliliters) mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
Lasmiditan 100 mg
n=36 Participants
Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
Placebo
Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan
|
1170 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 34
|
2470 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 35
|
—
|
Adverse Events
Lasmiditan 200 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Lasmiditan 100 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lasmiditan 200 mg
n=36 participants at risk
Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
Lasmiditan 100 mg
n=35 participants at risk
Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
Placebo
n=35 participants at risk
Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.
|
|---|---|---|---|
|
General disorders
Fatigue
|
11.1%
4/36 • Number of events 4 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
5.7%
2/35 • Number of events 2 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
25.0%
9/36 • Number of events 9 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
14.3%
5/35 • Number of events 5 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
5.6%
2/36 • Number of events 2 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
2.9%
1/35 • Number of events 1 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
3/36 • Number of events 3 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
8.6%
3/35 • Number of events 3 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.6%
2/36 • Number of events 2 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/35 • Up To 12 days
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Details of the Study and its results shall not be publicized in any form without prior consent of the Sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.
- Publication restrictions are in place
Restriction type: OTHER