Trial Outcomes & Findings for A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants (NCT NCT03310411)
NCT ID: NCT03310411
Last Updated: 2019-11-27
Results Overview
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) mean peak changes from baseline were calculated using a linear mixed-effects model with baseline, treatment, period, and sequence as fixed effects and participant as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Baseline (Day 1), Day 2
Results posted on
2019-11-27
Participant Flow
Crossover study with four periods. Participants were randomized to one of four treatment (Treatment A: 200 milligram (mg) lasmiditan + 100mg sumatriptan, Treatment B: 200mg lasmiditan + placebo, Treatment C: 100mg sumatriptan + placebo, Treatment D: placebo + placebo) period sequences. There was a washout of at least 4 days between each dosing day.
Participant milestones
| Measure |
Sequence 1
Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.
Period 1: 200 mg Lasmiditan + 100 mg sumatriptan, Period 2: 200 mg Lasmiditan + placebo Period 3: 100 mg Sumatriptan + placebo Period 4: Placebo + placebo
|
Sequence 2
Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.
Period 1: 200 mg Lasmiditan + placebo Period 2: 100 mg Sumatriptan + placebo Period 3: Placebo + placebo Period 4: 200 mg Lasmiditan + 100 mg sumatriptan
|
Sequence 3
Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.
Period 1: 100 mg Sumatriptan + placebo Period 2: Placebo + placebo Period 3: 200 mg Lasmiditan + 100 mg sumatriptan Period 4: 200 mg Lasmiditan + placebo
|
Sequence 4
Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo + placebo Period 2: 200 mg Lasmiditan + 100 mg sumatriptan Period 3: 200 mg Lasmiditan + placebo Period 4: 100 mg Sumatriptan + placebo
|
|---|---|---|---|---|
|
Period 1
STARTED
|
10
|
10
|
10
|
10
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
10
|
10
|
10
|
10
|
|
Period 1
COMPLETED
|
10
|
10
|
10
|
9
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Period 2
STARTED
|
10
|
10
|
10
|
9
|
|
Period 2
COMPLETED
|
10
|
10
|
10
|
9
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
10
|
10
|
10
|
9
|
|
Period 3
COMPLETED
|
10
|
10
|
10
|
9
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period Title: Period 4
STARTED
|
10
|
10
|
10
|
9
|
|
Period Title: Period 4
COMPLETED
|
10
|
10
|
10
|
9
|
|
Period Title: Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.
Period 1: 200 mg Lasmiditan + 100 mg sumatriptan, Period 2: 200 mg Lasmiditan + placebo Period 3: 100 mg Sumatriptan + placebo Period 4: Placebo + placebo
|
Sequence 2
Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.
Period 1: 200 mg Lasmiditan + placebo Period 2: 100 mg Sumatriptan + placebo Period 3: Placebo + placebo Period 4: 200 mg Lasmiditan + 100 mg sumatriptan
|
Sequence 3
Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.
Period 1: 100 mg Sumatriptan + placebo Period 2: Placebo + placebo Period 3: 200 mg Lasmiditan + 100 mg sumatriptan Period 4: 200 mg Lasmiditan + placebo
|
Sequence 4
Participants received single oral dose of Lasmiditan, sumatriptan and placebo tablets on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo + placebo Period 2: 200 mg Lasmiditan + 100 mg sumatriptan Period 3: 200 mg Lasmiditan + placebo Period 4: 100 mg Sumatriptan + placebo
|
|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall
n=40 Participants
Participants received single oral dose of 200 mg lasmiditan, 100 mg sumatriptan, 200 mg lasmiditan + 100 mg sumatriptan or placebo tablets on Day 1 of each treatment period according to their assigned treatment sequence.
|
|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 2Population: All enrolled participants who received at least one dose of study drug with evaluable blood pressure data.
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) mean peak changes from baseline were calculated using a linear mixed-effects model with baseline, treatment, period, and sequence as fixed effects and participant as a random effect.
Outcome measures
| Measure |
200 mg Lasmiditan + 100 mg Sumatriptan (A):
n=39 Participants
Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg Sumatriptan tablet on day1.
|
200 mg Lasmiditan + Placebo (B)
n=38 Participants
Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet on day 1.
|
100 mg Sumatriptan + Placebo (C)
n=39 Participants
Participants received single oral dose of 100mg sumatriptan tablet and single oral dose of placebo tablet on day 1.
|
Placebo + Placebo (D)
n=39 Participants
Participants received single oral dose of placebo for lasmiditan tablet and single oral dose of placebo for sumatriptan tablet on day 1.
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP)
|
13.81 Millimeters of mercury (mmHg)
Interval 11.83 to 15.79
|
12.17 Millimeters of mercury (mmHg)
Interval 10.47 to 13.87
|
13.63 Millimeters of mercury (mmHg)
Interval 11.65 to 15.61
|
11.42 Millimeters of mercury (mmHg)
Interval 9.74 to 13.09
|
SECONDARY outcome
Timeframe: Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 , 24 ,36 and 48 hours(h) postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
PK: Cmax of Lasmiditan and Sumatriptan was evaluated.
Outcome measures
| Measure |
200 mg Lasmiditan + 100 mg Sumatriptan (A):
n=39 Participants
Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg Sumatriptan tablet on day1.
|
200 mg Lasmiditan + Placebo (B)
n=39 Participants
Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet on day 1.
|
100 mg Sumatriptan + Placebo (C)
n=39 Participants
Participants received single oral dose of 100mg sumatriptan tablet and single oral dose of placebo tablet on day 1.
|
Placebo + Placebo (D)
n=38 Participants
Participants received single oral dose of placebo for lasmiditan tablet and single oral dose of placebo for sumatriptan tablet on day 1.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan and Sumatriptan
|
304 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
328 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
56.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
50.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
SECONDARY outcome
Timeframe: Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12, 24 ,36 and 48 h postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
PK: AUC(0 ∞) of Lasmiditan and Sumatriptan was evaluated.
Outcome measures
| Measure |
200 mg Lasmiditan + 100 mg Sumatriptan (A):
n=39 Participants
Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg Sumatriptan tablet on day1.
|
200 mg Lasmiditan + Placebo (B)
n=39 Participants
Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet on day 1.
|
100 mg Sumatriptan + Placebo (C)
n=39 Participants
Participants received single oral dose of 100mg sumatriptan tablet and single oral dose of placebo tablet on day 1.
|
Placebo + Placebo (D)
n=38 Participants
Participants received single oral dose of placebo for lasmiditan tablet and single oral dose of placebo for sumatriptan tablet on day 1.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0 ∞]) of Lasmiditan and Sumatriptan
|
2110 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
2170 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 33
|
253 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
240 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
Adverse Events
200 mg Lasmiditan + 100 mg Sumatriptan (A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
200 mg Lasmiditan + Placebo (B)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
100 mg Sumatriptan + Placebo (C)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo + Placebo (D)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
200 mg Lasmiditan + 100 mg Sumatriptan (A)
n=39 participants at risk
Participants received single oral dose of 200 mg lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet on day 1.
|
200 mg Lasmiditan + Placebo (B)
n=39 participants at risk
Participants received single oral dose of 200mg lasmiditan tablet and single oral dose of placebo tablet on day 1.
|
100 mg Sumatriptan + Placebo (C)
n=39 participants at risk
Participants received single oral dose of 100mg sumatriptan tablet and single oral dose of placebo tablet on day 1.
|
Placebo + Placebo (D)
n=40 participants at risk
Participants received single oral dose of placebo for lasmiditan tablet and single oral dose of placebo for sumatriptan tablet on day 1.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
5.1%
2/39 • Number of events 2 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
2.6%
1/39 • Number of events 1 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
0.00%
0/40 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
|
Nervous system disorders
Dizziness
|
7.7%
3/39 • Number of events 3 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
12.8%
5/39 • Number of events 5 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
2.6%
1/39 • Number of events 1 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
0.00%
0/40 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • Number of events 2 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
0.00%
0/39 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
5.1%
2/39 • Number of events 2 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
2.5%
1/40 • Number of events 1 • Up To 36 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment.
|
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