Trial Outcomes & Findings for A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants (NCT NCT04881747)
NCT ID: NCT04881747
Last Updated: 2023-03-23
Results Overview
PK: Cmax of Lasmiditan.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
Results posted on
2023-03-23
Participant Flow
Crossover study with three study periods, each participant received immediate release (IR) tablet as reference; oral disintegrating (OD) tablet with water and without water as test doses of 100 milligram (mg) lasmiditan according to their assigned treatment sequence, on Day 1 of each Period. The washout period between dosing in consecutive study periods was approximately 5 days.
Participant milestones
| Measure |
Sequence 1
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan OD with water.
|
Sequence 2
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan OD without water.
|
Sequence 3
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan IR.
|
Sequence 4
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD with water.
|
Sequence 5
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD without water.
|
Sequence 6
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan IR.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Period 1
Received At Least One Dose of Study Drug
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Period 1
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 Washout
STARTED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Period 1 Washout
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Period 1 Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Period 2
Received At Least One Dose of Study Drug
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Period 2
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 Washout
STARTED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Period 2 Washout
COMPLETED
|
6
|
8
|
8
|
7
|
7
|
7
|
|
Period 2 Washout
NOT COMPLETED
|
2
|
0
|
0
|
1
|
1
|
0
|
|
Period 3
STARTED
|
6
|
8
|
8
|
7
|
7
|
7
|
|
Period 3
Received At Least One Dose of Study Drug
|
6
|
8
|
8
|
7
|
7
|
7
|
|
Period 3
COMPLETED
|
6
|
8
|
8
|
7
|
7
|
7
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan OD with water.
|
Sequence 2
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan OD without water.
|
Sequence 3
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan IR.
|
Sequence 4
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD with water.
|
Sequence 5
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD without water.
|
Sequence 6
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan IR.
|
|---|---|---|---|---|---|---|
|
Period 2 Washout
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Period 2 Washout
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants
Baseline characteristics by cohort
| Measure |
Sequence 1
n=8 Participants
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan OD with water.
|
Sequence 2
n=8 Participants
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan OD without water.
|
Sequence 3
n=8 Participants
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan IR.
|
Sequence 4
n=8 Participants
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD with water.
|
Sequence 5
n=8 Participants
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD without water.
|
Sequence 6
n=7 Participants
Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan IR.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
43.5 years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
47.3 years
STANDARD_DEVIATION 12.5 • n=8 Participants
|
40.4 years
STANDARD_DEVIATION 12.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dosePopulation: All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data.
PK: Cmax of Lasmiditan.
Outcome measures
| Measure |
100 mg Lasmiditan IR (Reference)
n=46 Participants
Participants received 100 mg lasmiditan as IR tablet formulation administered orally.
|
100 mg Lasmiditan OD Without Water (Test)
n=46 Participants
Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.
|
100 mg Lasmiditan OD With Water (Test)
n=44 Participants
Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
|
140 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
123 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
124 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dosePopulation: All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data.
PK: AUC\[0-inf\] of Lasmiditan.
Outcome measures
| Measure |
100 mg Lasmiditan IR (Reference)
n=46 Participants
Participants received 100 mg lasmiditan as IR tablet formulation administered orally.
|
100 mg Lasmiditan OD Without Water (Test)
n=46 Participants
Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.
|
100 mg Lasmiditan OD With Water (Test)
n=44 Participants
Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.
|
|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan
|
937 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 39
|
884 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 39
|
881 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 39
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dosePopulation: All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data.
PK: AUC\[0-tlast\] of Lasmiditan.
Outcome measures
| Measure |
100 mg Lasmiditan IR (Reference)
n=46 Participants
Participants received 100 mg lasmiditan as IR tablet formulation administered orally.
|
100 mg Lasmiditan OD Without Water (Test)
n=46 Participants
Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.
|
100 mg Lasmiditan OD With Water (Test)
n=44 Participants
Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.
|
|---|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan
|
915 ng*h/mL
Geometric Coefficient of Variation 39
|
860 ng*h/mL
Geometric Coefficient of Variation 39
|
860 ng*h/mL
Geometric Coefficient of Variation 39
|
Adverse Events
100 mg Lasmiditan IR (Reference)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 mg Lasmiditan OD Without Water (Test)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 mg Lasmiditan OD With Water (Test)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60