Trial Outcomes & Findings for A Study of Lasmiditan in Participants With Migraine (NCT NCT03247790)
NCT ID: NCT03247790
Last Updated: 2019-12-02
Results Overview
PK: Cmax of Lasmiditan in Each Period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose
Results posted on
2019-12-02
Participant Flow
Participant milestones
| Measure |
Lasmiditan
Participants were administered a single oral dose of 200 mg lasmiditan tablet on 2 occasions (Day 1 of each period) during a migraine attack (Period 1) and during their inter-ictal period (Period 2).
|
|---|---|
|
Period 1: Migraine Attack
STARTED
|
16
|
|
Period 1: Migraine Attack
Received at Least One Dose of Study Drug
|
16
|
|
Period 1: Migraine Attack
COMPLETED
|
16
|
|
Period 1: Migraine Attack
NOT COMPLETED
|
0
|
|
Period 2: Inter-ictal Period
STARTED
|
16
|
|
Period 2: Inter-ictal Period
COMPLETED
|
16
|
|
Period 2: Inter-ictal Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Lasmiditan in Participants With Migraine
Baseline characteristics by cohort
| Measure |
Lasmiditan
n=16 Participants
Participants were administered a single oral dose of 200 mg lasmiditan tablet on 2 occasions (Day 1 of each period) during a migraine attack (Period 1) and during their inter-ictal period (Period 2).
|
|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 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
|
1 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
PK: Cmax of Lasmiditan in Each Period.
Outcome measures
| Measure |
Lasmiditan (Period 1)
n=16 Participants
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during migraine attack.
|
Lasmiditan (Period 2)
n=16 Participants
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during during inter-ictal period.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period
|
233 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
227 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
PK: AUC(0-∞) of Lasmiditan in Each Period.
Outcome measures
| Measure |
Lasmiditan (Period 1)
n=13 Participants
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during migraine attack.
|
Lasmiditan (Period 2)
n=14 Participants
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during during inter-ictal period.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period
|
1570 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 43
|
1640 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 46
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
PK: Cmax of Major Lasmiditan Metabolites \[M3, M8, M7, (S,R)-M18and (S,S)-M18\] in Each Period.
Outcome measures
| Measure |
Lasmiditan (Period 1)
n=16 Participants
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during migraine attack.
|
Lasmiditan (Period 2)
n=16 Participants
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during during inter-ictal period.
|
|---|---|---|
|
PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: M3
|
14.5 ng/mL
Geometric Coefficient of Variation 54
|
14.8 ng/mL
Geometric Coefficient of Variation 41
|
|
PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: M8
|
319 ng/mL
Geometric Coefficient of Variation 34
|
326 ng/mL
Geometric Coefficient of Variation 30
|
|
PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: M7
|
77.2 ng/mL
Geometric Coefficient of Variation 52
|
85.9 ng/mL
Geometric Coefficient of Variation 42
|
|
PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: (S,R)-M18
|
57.0 ng/mL
Geometric Coefficient of Variation 31
|
59.5 ng/mL
Geometric Coefficient of Variation 34
|
|
PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: (S,S)-M18
|
14.0 ng/mL
Geometric Coefficient of Variation 37
|
15.0 ng/mL
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
PK: AUC(0-∞) of Major Lasmiditan Metabolites \[M3, M8, M7, (S,R)-M18and (S,S)-M18\] in Each Period.
Outcome measures
| Measure |
Lasmiditan (Period 1)
n=16 Participants
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during migraine attack.
|
Lasmiditan (Period 2)
n=16 Participants
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during during inter-ictal period.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: M8
|
6180 ng*h/mL
Geometric Coefficient of Variation 28
|
6380 ng*h/mL
Geometric Coefficient of Variation 27
|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: M7
|
820 ng*h/mL
Geometric Coefficient of Variation 80
|
949 ng*h/mL
Geometric Coefficient of Variation 60
|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: (S,R)-M18
|
1460 ng*h/mL
Geometric Coefficient of Variation 33
|
1570 ng*h/mL
Geometric Coefficient of Variation 34
|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: M3
|
68.0 ng*h/mL
Geometric Coefficient of Variation 44
|
77.8 ng*h/mL
Geometric Coefficient of Variation 33
|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
Metabolite: (S,S)-M18
|
363 ng*h/mL
Geometric Coefficient of Variation 29
|
318 ng*h/mL
Geometric Coefficient of Variation 24
|
Adverse Events
Lasmiditan (Period 1)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Lasmiditan (Period 2)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lasmiditan (Period 1)
n=16 participants at risk
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during migraine attack.
|
Lasmiditan (Period 2)
n=16 participants at risk
Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during inter-ictal period.
|
|---|---|---|
|
Eye disorders
Photophobia
|
56.2%
9/16 • Number of events 9 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • Number of events 2 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
6/16 • Number of events 8 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 3 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
2/16 • Number of events 2 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/14 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood urea increased
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram QT prolonged
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram T wave abnormal
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
31.2%
5/16 • Number of events 6 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
37.5%
6/16 • Number of events 6 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Lethargy
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
100.0%
16/16 • Number of events 31 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.0%
4/16 • Number of events 5 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
56.2%
9/16 • Number of events 9 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.0%
4/16 • Number of events 4 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Phonophobia
|
25.0%
4/16 • Number of events 4 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Flushing
|
12.5%
2/16 • Number of events 2 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
2/16 • Number of events 2 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/16 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 58 Days
All enrolled participants who received at least one dose of study drug and had at least one post-dose safety assessment. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
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