Trial Outcomes & Findings for A Study of Lasmiditan in Healthy Volunteers (NCT NCT04749914)
NCT ID: NCT04749914
Last Updated: 2024-02-01
Results Overview
PK: Cmax of Dabigatran.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
97 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose.
Results posted on
2024-02-01
Participant Flow
This study consisted of two parts - Part 1 and Part 2, each consisting of two periods. Part 1 studied dabigatran P-glycoprotein (P-gp) drug-drug interaction with lasmiditan. Part 2 studied rosuvastatin breast cancer resistance protein (BCRP) drug-drug interaction with lasmiditan.
Participant milestones
| Measure |
150 Milligram (mg) Dabigatran Etexilate-Part 1 Period 1
Participants received a single oral dose 150 mg dabigatran etexilate on Day 1.
|
150 mg Dabigatran Etexilate + 200 mg Lasmiditan-Part 1 Period 2
After Period 1, participants received 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10.
|
10 mg Rosuvastatin-Part 2 Period 1
Participants received a single oral dose of 10 mg rosuvastatin on Day 1.
|
10 mg Rosuvastatin + 200 mg Lasmiditan-Part 2 Period 2
After Period 1, participants received 200 mg lasmiditan QD on Days 8 and 9, and then received 10 mg rosuvastatin along with 200 mg lasmiditan on Day 10.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
66
|
0
|
31
|
0
|
|
Period 1
Received at Least One Dose of Study Drug
|
66
|
0
|
30
|
0
|
|
Period 1
COMPLETED
|
64
|
0
|
30
|
0
|
|
Period 1
NOT COMPLETED
|
2
|
0
|
1
|
0
|
|
Period 2
STARTED
|
0
|
64
|
0
|
30
|
|
Period 2
Received at Least One Dose of Study Drug
|
0
|
64
|
0
|
30
|
|
Period 2
COMPLETED
|
0
|
64
|
0
|
30
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
150 Milligram (mg) Dabigatran Etexilate-Part 1 Period 1
Participants received a single oral dose 150 mg dabigatran etexilate on Day 1.
|
150 mg Dabigatran Etexilate + 200 mg Lasmiditan-Part 1 Period 2
After Period 1, participants received 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10.
|
10 mg Rosuvastatin-Part 2 Period 1
Participants received a single oral dose of 10 mg rosuvastatin on Day 1.
|
10 mg Rosuvastatin + 200 mg Lasmiditan-Part 2 Period 2
After Period 1, participants received 200 mg lasmiditan QD on Days 8 and 9, and then received 10 mg rosuvastatin along with 200 mg lasmiditan on Day 10.
|
|---|---|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Lasmiditan in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
150 mg Dabigatran Etexilate-Part 1 Period 1
n=66 Participants
Participants received a single oral dose 150 mg dabigatran etexilate on Day 1.
|
10 mg Rosuvastatin-Part 2 Period 1
n=30 Participants
Participants received a single oral dose of 10 mg rosuvastatin on Day 1.
|
Total
n=96 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
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
64 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
93 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
66 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose.Population: All participants from Part 1 who received at least 1 dose of Dabigatran etexilate and had evaluable PK data.
PK: Cmax of Dabigatran.
Outcome measures
| Measure |
150 mg Dabigatran Etexilate (Part 1 Period 1)
n=66 Participants
Participants received a single oral dose of 150 mg dabigatran etexilate on Day 1.
|
150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)
n=64 Participants
Participants received 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10. All treatments were administered orally.
|
|---|---|---|
|
Part 1 Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran to Assess P-glycoprotein (P-gp) Activity.
|
138 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 55
|
168 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours post-dose.Population: All participants from Part 2 who received at least 1 dose of Rosuvastatin and had evaluable PK data.
PK: Cmax of Rosuvastatin.
Outcome measures
| Measure |
150 mg Dabigatran Etexilate (Part 1 Period 1)
n=30 Participants
Participants received a single oral dose of 150 mg dabigatran etexilate on Day 1.
|
150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)
n=30 Participants
Participants received 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10. All treatments were administered orally.
|
|---|---|---|
|
Part 2 PK: Cmax of Rosuvastatin to Assess Breast Cancer Resistance Protein (BCRP) Activity.
|
8.23 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
8.85 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose.Population: All participants from Part 1 who received at least 1 dose of Dabigatran etexilate had evaluable PK data.
PK: AUC\[0-∞\] of Dabigatran
Outcome measures
| Measure |
150 mg Dabigatran Etexilate (Part 1 Period 1)
n=66 Participants
Participants received a single oral dose of 150 mg dabigatran etexilate on Day 1.
|
150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)
n=64 Participants
Participants received 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10. All treatments were administered orally.
|
|---|---|---|
|
Part 1 PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] ) of Dabigatran to Assess P-gp Activity.
|
1240 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 53
|
1540 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 50
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours post-dose.Population: All participants from Part 2 who received at least 1 dose of Rosuvastatin and had evaluable PK data.
PK: AUC\[0-∞\] of Rosuvastatin
Outcome measures
| Measure |
150 mg Dabigatran Etexilate (Part 1 Period 1)
n=30 Participants
Participants received a single oral dose of 150 mg dabigatran etexilate on Day 1.
|
150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)
n=30 Participants
Participants received 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10. All treatments were administered orally.
|
|---|---|---|
|
Part 2 PK: AUC[0-∞] of Rosuvastatin to Assess BCRP Activity.
|
58.6 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 60
|
67.3 nanogram * hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 52
|
Adverse Events
150 Milligram (mg) Dabigatran Etexilate (Part 1 Period 1)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
200 mg Lasmiditan (Part 1 Period 2)
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
10 mg Rosuvastatin (Part 2 Period 1)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
200 mg Lasmiditan (Part 2 Period 2)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
10 mg Rosuvastatin + 200 mg Lasmiditan (Part 2 Period 2)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
150 Milligram (mg) Dabigatran Etexilate (Part 1 Period 1)
n=66 participants at risk
Participants received a single oral dose 150 mg dabigatran etexilate on Day 1.
|
200 mg Lasmiditan (Part 1 Period 2)
n=64 participants at risk
After Part 1 Period 1, participants received oral doses of 200 mg lasmiditan once daily (QD) on Days 8 and 9.
|
150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)
n=64 participants at risk
Following lasmiditan administration on Days 8 and 9, participants received 150 mg dabigatran etexilate + 200 mg lasmiditan administered orally on Day 10.
|
10 mg Rosuvastatin (Part 2 Period 1)
n=30 participants at risk
Participants received a single oral dose of 10 mg rosuvastatin on Day 1.
|
200 mg Lasmiditan (Part 2 Period 2)
n=30 participants at risk
After Part 2 Period 1, participants received oral doses of 200 mg lasmiditan QD on Days 8 and 9.
|
10 mg Rosuvastatin + 200 mg Lasmiditan (Part 2 Period 2)
n=30 participants at risk
Following lasmiditan administration on Days 8 and 9, participants received 10 mg rosuvastatin + 200 mg lasmiditan administered orally on Day 10.
|
|---|---|---|---|---|---|---|
|
General disorders
Catheter site bruise
|
12.1%
8/66 • Number of events 12 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.1%
2/64 • Number of events 2 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
17.2%
11/64 • Number of events 13 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 2 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site erythema
|
9.1%
6/66 • Number of events 6 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
6.2%
4/64 • Number of events 4 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
6.2%
4/64 • Number of events 4 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 2 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
13.3%
4/30 • Number of events 4 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
10.0%
3/30 • Number of events 3 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site pain
|
12.1%
8/66 • Number of events 8 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
7.8%
5/64 • Number of events 5 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
6.2%
4/64 • Number of events 4 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site swelling
|
1.5%
1/66 • Number of events 1 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
6.2%
4/64 • Number of events 4 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
7.8%
5/64 • Number of events 5 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
10.6%
7/66 • Number of events 8 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
1.6%
1/64 • Number of events 1 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
9.4%
6/64 • Number of events 7 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
10.0%
3/30 • Number of events 3 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
10.0%
3/30 • Number of events 3 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.5%
1/66 • Number of events 1 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
6.2%
4/64 • Number of events 5 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.1%
2/64 • Number of events 2 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
6.7%
2/30 • Number of events 3 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/66 • Number of events 1 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
35.9%
23/64 • Number of events 31 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
10.9%
7/64 • Number of events 7 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
23.3%
7/30 • Number of events 9 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
10.0%
3/30 • Number of events 3 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/66 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
15.6%
10/64 • Number of events 10 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
4.7%
3/64 • Number of events 3 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/66 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
6.2%
4/64 • Number of events 4 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
4.7%
3/64 • Number of events 3 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/66 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
14.1%
9/64 • Number of events 10 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
3.1%
2/64 • Number of events 2 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
23.3%
7/30 • Number of events 9 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
0.00%
0/30 • Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place