Trial Outcomes & Findings for A Study of Lasmiditan in Healthy Japanese and Caucasian Participants (NCT NCT03579940)
NCT ID: NCT03579940
Last Updated: 2019-11-29
Results Overview
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Baseline up to Day 20
Results posted on
2019-11-29
Participant Flow
Crossover study with three study periods, each participant received single/repeated oral doses of 50, 100, 200, 400, or 2 X 200 milligram (mg) lasmiditan, placebo, or 2 X placebo, according to their assigned treatment sequence, on Day 1 of each Period. The washout period between dosing in consecutive study periods was approximately 72 hours.
Participant milestones
| Measure |
Cohort 1: Sequence 1: Japanese
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan.
|
Cohort 1: Sequence 2: Japanese
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan.
|
Cohort 1: Sequence 3: Japanese
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo.
|
Cohort 2: Sequence 1: Japanese
Participants received single, repeated oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart).
|
Cohort 2: Sequence 2: Japanese
Participants received single, repeated oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart).
|
Cohort 2: Sequence 3: Japanese
Participants received single oral doses of Lasmiditan and repeated oral doses of placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 100 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X Placebo (2 single doses administered 2 hours apart).
|
Cohort 2: Sequence 4: Japanese
Participants received single, repeated oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.
Period 1: 200 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart).
|
Cohort 3: Sequence 1: Caucasian
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan.
|
Cohort 3: Sequence 2: Caucasian
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan.
|
Cohort 3: Sequence 3: Caucasian
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo.
|
Cohort 3: Sequence 4: Caucasian
Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan .
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
3
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
2
|
3
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
3
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
2
|
3
|
|
Period 1
COMPLETED
|
3
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
2
|
3
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
3
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
2
|
3
|
|
Period 2
COMPLETED
|
3
|
2
|
1
|
2
|
2
|
2
|
3
|
3
|
3
|
2
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
3
|
2
|
1
|
2
|
2
|
2
|
3
|
3
|
3
|
2
|
3
|
|
Period 3
COMPLETED
|
3
|
2
|
1
|
2
|
2
|
2
|
3
|
3
|
3
|
2
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Sequence 1: Japanese
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan.
|
Cohort 1: Sequence 2: Japanese
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan.
|
Cohort 1: Sequence 3: Japanese
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo.
|
Cohort 2: Sequence 1: Japanese
Participants received single, repeated oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart).
|
Cohort 2: Sequence 2: Japanese
Participants received single, repeated oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart).
|
Cohort 2: Sequence 3: Japanese
Participants received single oral doses of Lasmiditan and repeated oral doses of placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 100 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X Placebo (2 single doses administered 2 hours apart).
|
Cohort 2: Sequence 4: Japanese
Participants received single, repeated oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.
Period 1: 200 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart).
|
Cohort 3: Sequence 1: Caucasian
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan.
|
Cohort 3: Sequence 2: Caucasian
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan.
|
Cohort 3: Sequence 3: Caucasian
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo.
|
Cohort 3: Sequence 4: Caucasian
Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan .
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Lasmiditan in Healthy Japanese and Caucasian Participants
Baseline characteristics by cohort
| Measure |
Cohort 1: Sequence 1: Japanese
n=3 Participants
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan.
|
Cohort 1: Sequence 2: Japanese
n=2 Participants
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan.
|
Cohort 1: Sequence 3: Japanese
n=2 Participants
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo.
|
Cohort 2: Sequence 1: Japanese
n=2 Participants
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart).
|
Cohort 2: Sequence 2: Japanese
n=2 Participants
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart).
|
Cohort 2: Sequence 3: Japanese
n=2 Participants
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 100 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X Placebo (2 single doses administered 2 hours apart).
|
Cohort 2: Sequence 4: Japanese
n=3 Participants
Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.
Period 1: 200 mg Lasmiditan Period 2: 400 mg Lasmiditan and Period 3: 2 X 200 mg Lasmiditan (2 single doses administered 2 hours apart).
|
Cohort 3: Sequence 1: Caucasian
n=3 Participants
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan.
|
Cohort 3: Sequence 2: Caucasian
n=3 Participants
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: Placebo and Period 3: 200 mg Lasmiditan.
|
Cohort 3: Sequence 3: Caucasian
n=2 Participants
Participants received single oral doses of Lasmiditan and placebo on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: Placebo.
|
Cohort 3: Sequence 4: Caucasian
n=3 Participants
Participants received single oral doses of Lasmiditan on day 1 of each treatment period as per the below dosing sequence.
Period 1: 50 mg Lasmiditan Period 2: 100 mg Lasmiditan and Period 3: 200 mg Lasmiditan .
|
Total
n=27 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Age, Categorical
>=65 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
25 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
16 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
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
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
3 participants
n=8 Participants
|
3 participants
n=24 Participants
|
3 participants
n=42 Participants
|
2 participants
n=42 Participants
|
3 participants
n=42 Participants
|
27 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 20Population: All enrolled participants who received at least one dose of study drug.
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo: Japanese
n=10 Participants
Participants received single oral dose of placebo on day 1.
|
Placebo: Caucasian
n=8 Participants
Participants received single oral dose of placebo on day 1.
|
2 x Placebo: Japanese
n=2 Participants
Participants received 2 x Placebo (2 single oral doses administered 2 hours apart) on day 1.
|
50 mg Lasmiditan: Japanese
n=6 Participants
Participants received single oral dose of 50 mg lasmiditan on day 1.
|
50 mg Lasmiditan: Caucasian
n=8 Participants
Participants received single oral dose of 50 mg lasmiditan on day 1.
|
100 mg Lasmiditan: Japanese
n=7 Participants
Participants received single oral dose of 100 mg lasmiditan on day 1.
|
100 mg Lasmiditan: Caucasian
n=8 Participants
Participants received single oral dose of 100 mg lasmiditan on day 1.
|
200 mg Lasmiditan: Japanese
n=8 Participants
Participants received single oral dose of 200 mg lasmiditan on day 1
|
200 mg Lasmiditan: Caucasian
n=9 Participants
Participants received single oral dose of 200 mg lasmiditan on day 1.
|
400 mg Lasmiditan: Japanese
n=7 Participants
Participants received single oral dose of 400 mg lasmiditan on day 1.
|
2 X 200 mg Lasmiditan: Japanese
n=7 Participants
Participants received 2 X 200 mg lasmiditan (2 single oral doses administered 2 hours apart) on day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdosePopulation: 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 was evaluated.
Outcome measures
| Measure |
Placebo: Japanese
n=6 Participants
Participants received single oral dose of placebo on day 1.
|
Placebo: Caucasian
n=8 Participants
Participants received single oral dose of placebo on day 1.
|
2 x Placebo: Japanese
n=7 Participants
Participants received 2 x Placebo (2 single oral doses administered 2 hours apart) on day 1.
|
50 mg Lasmiditan: Japanese
n=8 Participants
Participants received single oral dose of 50 mg lasmiditan on day 1.
|
50 mg Lasmiditan: Caucasian
n=8 Participants
Participants received single oral dose of 50 mg lasmiditan on day 1.
|
100 mg Lasmiditan: Japanese
n=9 Participants
Participants received single oral dose of 100 mg lasmiditan on day 1.
|
100 mg Lasmiditan: Caucasian
n=7 Participants
Participants received single oral dose of 100 mg lasmiditan on day 1.
|
200 mg Lasmiditan: Japanese
n=7 Participants
Participants received single oral dose of 200 mg lasmiditan on day 1
|
200 mg Lasmiditan: Caucasian
Participants received single oral dose of 200 mg lasmiditan on day 1.
|
400 mg Lasmiditan: Japanese
Participants received single oral dose of 400 mg lasmiditan on day 1.
|
2 X 200 mg Lasmiditan: Japanese
Participants received 2 X 200 mg lasmiditan (2 single oral doses administered 2 hours apart) on day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period
|
362 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 46
|
366 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 78
|
791 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 22
|
826 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 70
|
1540 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 26
|
2120 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 50
|
3780 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 32
|
3500 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
PK: Cmax of Lasmiditan in Each Period was evaluated.
Outcome measures
| Measure |
Placebo: Japanese
n=6 Participants
Participants received single oral dose of placebo on day 1.
|
Placebo: Caucasian
n=8 Participants
Participants received single oral dose of placebo on day 1.
|
2 x Placebo: Japanese
n=7 Participants
Participants received 2 x Placebo (2 single oral doses administered 2 hours apart) on day 1.
|
50 mg Lasmiditan: Japanese
n=8 Participants
Participants received single oral dose of 50 mg lasmiditan on day 1.
|
50 mg Lasmiditan: Caucasian
n=8 Participants
Participants received single oral dose of 50 mg lasmiditan on day 1.
|
100 mg Lasmiditan: Japanese
n=9 Participants
Participants received single oral dose of 100 mg lasmiditan on day 1.
|
100 mg Lasmiditan: Caucasian
n=7 Participants
Participants received single oral dose of 100 mg lasmiditan on day 1.
|
200 mg Lasmiditan: Japanese
n=7 Participants
Participants received single oral dose of 200 mg lasmiditan on day 1
|
200 mg Lasmiditan: Caucasian
Participants received single oral dose of 200 mg lasmiditan on day 1.
|
400 mg Lasmiditan: Japanese
Participants received single oral dose of 400 mg lasmiditan on day 1.
|
2 X 200 mg Lasmiditan: Japanese
Participants received 2 X 200 mg lasmiditan (2 single oral doses administered 2 hours apart) on day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period
|
54.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
52.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 84
|
122 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
101 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 94
|
249 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
309 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
680 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
519 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
Adverse Events
Placebo: Japanese
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo: Caucasian
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 x Placebo: Japanese
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
50 mg Lasmiditan: Japanese
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
50 mg Lasmiditan: Caucasian
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
100 mg Lasmiditan: Japanese
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
100 mg Lasmiditan: Caucasian
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg Lasmiditan: Japanese
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
200 mg Lasmiditan: Caucasian
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
400 mg Lasmiditan: Japanese
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
2 x 200 mg Lasmiditan: Japanese
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo: Japanese
n=10 participants at risk
Participants received single oral dose of placebo on day 1.
|
Placebo: Caucasian
n=8 participants at risk
Participants received single oral dose of placebo on day 1.
|
2 x Placebo: Japanese
n=2 participants at risk
Participants received 2 X Placebo (2 single oral doses administered 2 hours apart) on day 1.
|
50 mg Lasmiditan: Japanese
n=6 participants at risk
Participants received single oral dose of 50 mg lasmiditan on day 1.
|
50 mg Lasmiditan: Caucasian
n=8 participants at risk
Participants received single oral dose of 50 mg lasmiditan on day 1.
|
100 mg Lasmiditan: Japanese
n=7 participants at risk
Participants received single oral dose of 100 mg lasmiditan on day 1.
|
100 mg Lasmiditan: Caucasian
n=8 participants at risk
Participants received single oral dose of 100 mg lasmiditan on day 1.
|
200 mg Lasmiditan: Japanese
n=8 participants at risk
Participants received single oral dose of 200 mg lasmiditan on day 1.
|
200 mg Lasmiditan: Caucasian
n=9 participants at risk
Participants received single oral dose of 200 mg lasmiditan on day 1.
|
400 mg Lasmiditan: Japanese
n=7 participants at risk
Participants received single oral dose of 400 mg lasmiditan on day 1.
|
2 x 200 mg Lasmiditan: Japanese
n=7 participants at risk
Participants received 2 X 200 mg lasmiditan (2 single oral doses administered 2 hours apart) on day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Feeling cold
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 3 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 3 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 3 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 3 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 3 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/10 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/9 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up To 20 days
All enrolled 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