Trial Outcomes & Findings for A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate (NCT NCT03308669)

Last Updated: 2019-11-27

Results Overview

A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

Baseline through Day 24

Results posted on

2019-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Sequence 1: 50 mg Topiramate + Placebo Placebo film-coated tablets administered orally once in the morning of Day 1 and once in the morning of Day 14. 25 milligrams (mg) topiramate administered orally on Day 3, two oral doses separated by approximately 12 hours of a single 25-mg topiramate tablet on Days 4 to 7, and two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13. Final topiramate dosing (2 25-mg tablets) was co-administered with 1 oral dose of placebo.	Treatment Sequence 2: 50 mg Topiramate + 200 mg Lasmiditan 200 mg lasmiditan film-coated tablet administered orally once in the morning of Day 1 and once in the morning of Day 14. 25 milligrams (mg) topiramate administered orally on Day 3, two oral doses separated by approximately 12 hours of a single 25-mg topiramate tablet on Days 4 to 7, and two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13. Final topiramate dosing (2 25-mg tablets) was co-administered with 1 oral dose of lasmiditan.
Overall Study STARTED	10	20
Overall Study Received at Least One Dose of Study Drug	10	20
Overall Study COMPLETED	10	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Sequence 1: 50 mg Topiramate + Placebo n=10 Participants Placebo film-coated tablets administered orally once in the morning of Day 1 and once in the morning of Day 14. Two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13.	Treatment Sequence 2: 50 mg Topiramate + 200 mg Lasmiditan n=20 Participants 200 mg lasmiditan film-coated tablet administered orally once in the morning of Day 1 and once in the morning of Day 14. Two oral doses of 50 mg (2 × 25-mg tablets) separated by approximately 12 hours on Days 8 to 13.	Total n=30 Participants Total of all reporting groups
Age, Continuous	44.3 years STANDARD_DEVIATION 13.3 • n=5 Participants	44.0 years STANDARD_DEVIATION 13.6 • n=7 Participants	44.1 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	19 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	19 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	1 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 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 United States	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through Day 24

Population: All participants who received at least one dose of study drug.

A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo administered orally, alone	200 mg Lasmiditan n=20 Participants Lasmiditan administered orally, alone	Topiramate Alone n=30 Participants Topiramate administered orally, alone	50 mg Topiramate + 200 mg Lasmiditan n=20 Participants Topiramate administered orally, alone, and co-administered with oral lasmiditan	50 mg Topiramate + Placebo n=10 Participants Topiramate administered orally, alone, and co-administered with oral placebo
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

SECONDARY outcome

Timeframe: Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)

Population: All participants who received at least one dose of lasmiditan or topiramate and had evaluable PK data.

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate when administered alone on Day 13 and when coadministered with lasmiditan on Day 14

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Placebo administered orally, alone	200 mg Lasmiditan n=20 Participants Lasmiditan administered orally, alone	Topiramate Alone Topiramate administered orally, alone	50 mg Topiramate + 200 mg Lasmiditan Topiramate administered orally, alone, and co-administered with oral lasmiditan	50 mg Topiramate + Placebo Topiramate administered orally, alone, and co-administered with oral placebo
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14	4300 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 15	4190 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 16	—	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

Population: All participants who received at least one dose of lasmiditan or topiramate and had evaluable PK data.

PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo administered orally, alone	200 mg Lasmiditan n=20 Participants Lasmiditan administered orally, alone	Topiramate Alone Topiramate administered orally, alone	50 mg Topiramate + 200 mg Lasmiditan Topiramate administered orally, alone, and co-administered with oral lasmiditan	50 mg Topiramate + Placebo Topiramate administered orally, alone, and co-administered with oral placebo
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14	276 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 41	301 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 35	—	—	—

SECONDARY outcome

Timeframe: Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)

Population: All participants who received at least one dose of lasmiditan or topiramate and have evaluable PK data.

PK: Area Under the Plasma Concentration versus Time Curve During One Dosing Interval (AUC \[tau\]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Placebo administered orally, alone	200 mg Lasmiditan n=20 Participants Lasmiditan administered orally, alone	Topiramate Alone Topiramate administered orally, alone	50 mg Topiramate + 200 mg Lasmiditan Topiramate administered orally, alone, and co-administered with oral lasmiditan	50 mg Topiramate + Placebo Topiramate administered orally, alone, and co-administered with oral placebo
PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14	42600 nanogramshour per milliliter(ngh/mL) Geometric Coefficient of Variation 15	42800 nanogramshour per milliliter(ngh/mL) Geometric Coefficient of Variation 17	—	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

Population: All participants who received at least one dose of lasmiditan or topiramate and have evaluable PK data.

PK: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14