CompletedNCT03252015Updated Jan 10, 2020Results posted

A Study of Multiple Doses of Lasmiditan in Healthy Participants

A Phase 1 interventional study of Probe Drug Cocktail and Lasmiditan in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-10.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it.

When drugs are taken together, one or all of the drugs used in combination may be affected. This study will also evaluate the concentrations in the blood of a probe drug cocktail taken alone and in combination with lasmiditan. Information about any side effects that may occur will also be collected.

The study has two parts. Participants will only enroll in one part. This study will last about 25 days for group 1 and 22 days for group 2, not including screening. Screening is required within 28 days prior to the start of the study.

This study is for research purposes only and is not intended to treat any medical condition.

Conditions studied

Healthy

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy males or females, as determined by medical history and physical examination
Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

Exclusion criteria

Exclusion Criteria:

Have participated, within the last 30 days, in a clinical study involving an Investigational Product (IP)
Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan
Have clinically significant abnormality in the 12-lead ECG, including corrected QT interval (QTc) with Fridericia's correction (QTcF) greater than (>) 450 milliseconds (ms) for men or >470 ms for women or any abnormality that in the opinion of the investigator increases the risk of participating in the study (not limited to significant bradycardia or heart block)
History of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression), have a recent history of a suicide attempt (30 days within screening visit and any time between screening visit and baseline); or are clinically judged by the investigator to be at risk for suicide
History of hypoglycemia
Known history of glucose-6-phosphate dehydrogenase deficiency
Are taking a concomitant medication or a dietary substance that affects cytochrome P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 70 participants (actual)

Study arms

Experimental
Probe Drug Cocktail (Cohort 1a)
Probe Drug Cocktail administered orally on Day -3.
Drug: Probe Drug Cocktail
Experimental
200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)
200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
Drug: Probe Drug Cocktail · Drug: Lasmiditan
Placebo comparator
Placebo+Probe Drug Cocktail (Cohort 1b)
Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.
Drug: Probe Drug Cocktail · Drug: Placebo
Experimental
400 mg Lasmiditan (Cohort 2a)
400 mg lasmiditan administered orally for 7 days.
Drug: Lasmiditan
Experimental
Placebo (Cohort 2b)
Placebo administered orally for 7 days.
Drug: Placebo

Interventions

DrugProbe Drug Cocktail
Administered orally
DrugLasmiditan
Administered orally
Also known as: LY573144
DrugPlacebo
Administered orally

What researchers measure

Primary outcomes

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.
Time frame: Baseline through 14 days after last administration of study drug

Secondary outcomes

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1
PK: Cmax of lasmiditan
Time frame: Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7
PK: Cmax of lasmiditan Day 7
Time frame: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1
PK: AUCtau of lasmiditan
Time frame: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7
PK AUCtau of lasmiditan
Time frame: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score
BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.
Time frame: PreDose Day 7 and Day 21
Physician Withdrawal Checklist (PWC)Total Score
Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Time frame: Day 7 and Day 21 at anytime
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1
Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.
Time frame: Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7
Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.
Time frame: Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam
PK: Cmax of midazolam.
Time frame: Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7
PK of midazolam.
Time frame: Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose

Results

Posted Jan 10, 2020

Participant flow

Participant flow — Overall Study
Milestone	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)
Started	12	28	15	15
Received at least 1 dose of study drug	12	28	15	15
Completed	11	27	14	14
Not completed	1	1	1	1
Withdrew: Withdrawal by subject	0	1	1	0
Withdrew: Adverse event	1	0	0	1

Outcome measures

PrimaryNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.

Time frame:: Baseline through 14 days after last administration of study drug
Reported as:: Count of participants · Participants

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Participants	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0	0	0	0

SecondaryPharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1

PK: Cmax of lasmiditan

Time frame:: Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose
Reported as:: Geometric mean · nanograms per milliliter (ng/mL)

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1
nanograms per milliliter (ng/mL)	200 mg Lasmiditan	400 mg Lasmiditan
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1	349 ± 32	750 ± 44

SecondaryPharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7

PK: Cmax of lasmiditan Day 7

Time frame:: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose
Reported as:: Geometric mean · ng/mL

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7
ng/mL	200 mg Lasmiditan	400 mg Lasmiditan
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7	353 ± 29	808 ± 41

SecondaryPharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1

PK: AUCtau of lasmiditan

Time frame:: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose
Reported as:: Geometric mean · nanograms times hour per milliLiter

Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1
nanograms times hour per milliLiter	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2b (400 mg Lasmiditan)
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1	2070 ± 32	4530 ± 39

SecondaryPharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7

PK AUCtau of lasmiditan

Time frame:: Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose
Reported as:: Geometric mean · nanograms time hours per milliLiter

Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7
nanograms time hours per milliLiter	200 mg Lasmiditan+Probe Drug Cocktail (Cohort 1)	400 mg Lasmiditan (Cohort 2)
Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7	2160 ± 29	4690 ± 36

SecondaryBenzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score

BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.

Time frame:: PreDose Day 7 and Day 21
Reported as:: Mean · units on a scale

Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score
units on a scale	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)
Day 7	0.0 ± 0.0	0.2 ± 0.6	0.0 ± 0.0	0.1 ± 0.3
Day 21	0.0 ± 0.0	0.0 ± 0.0	0.0 ± 0.0	0.0 ± 0.0

Statistical analysis

Cohort 1a (Placebo+Probe Drug Cocktail) vs Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) · Mean difference (final values): -0.182 · 95% CI -0.412 to 0.049
Cohort 2a (Placebo) vs Cohort 2b (400 mg Lasmiditan) · Mean difference (final values): 0.071 · 95% CI -0.081 to 0.224
Cohort 1a (Placebo+Probe Drug Cocktail) vs Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) · Mean difference (final values): 0.000 · 95% CI 0.000 to 0.000
Cohort 2a (Placebo) vs Cohort 2b (400 mg Lasmiditan) · Mean difference (final values): 0.000 · 95% CI 0.000 to 0.000

SecondaryPhysician Withdrawal Checklist (PWC)Total Score

Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.

Time frame:: Day 7 and Day 21 at anytime
Reported as:: Mean · units on a scale

Physician Withdrawal Checklist (PWC)Total Score
units on a scale	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)
Day 7 Predose	0.2 ± 0.4	0.0 ± 0.2	0.0 ± 0.0	0.1 ± 0.3
Day 21	0.0 ± 0.0	0.1 ± 0.4	0.0 ± 0.0	0.0 ± 0.0

Statistical analysis

Cohort 1a (Placebo+Probe Drug Cocktail) vs Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) · Mean difference (final values): -0.145 · 95% CI -0.340 to 0.050
Cohort 2a (Placebo) vs Cohort 2b (400 mg Lasmiditan) · Mean difference (final values): 0.071 · 95% CI -0.081 to 0.224
Cohort 1a (Placebo+Probe Drug Cocktail) vs Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail) · Mean difference (final values): 0.071 · 95% CI -0.151 to 0.294
Cohort 2a (Placebo) vs Cohort 2b (400 mg Lasmiditan) · Mean difference (final values): 0.000 · 95% CI 0.000 to 0.000

SecondaryPharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1

Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.

Time frame:: Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose
Reported as:: Geometric mean · mg/mL

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1
mg/mL	200 mg Lasmiditan	400 mg Lasmiditan
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1	407 ± 24	964 ± 18

SecondaryPharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7

Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.

Time frame:: Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose
Reported as:: Geometric mean · ng/mL

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7
ng/mL	200 mg Lasmiditan+Probe Drug Cocktail (Cohort 1)	400 mg Lasmiditan (Cohort 2)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7	641 ± 20	1500 ± 20

SecondaryPharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam

PK: Cmax of midazolam.

Time frame:: Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,
Reported as:: Geometric mean · nanograms per milliLiter

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam
nanograms per milliLiter	Participants Who Received Probe Drug Cocktail
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam	10. ± 39

SecondaryPharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7

PK of midazolam.

Time frame:: Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose
Reported as:: Geometric mean · nanograms per milliliter

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7
nanograms per milliliter	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7	10.1 ± 40	9.45 ± 34

Adverse events

Collected over Baseline through 28 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Probe Drug Cocktail (Cohort 1)	0/40 (0%)	0/40 (0%)	0/40 (0%)
200 mg Lasmiditan QD (Cohort 1)	0/28 (0%)	0/28 (0%)	13/28 (46.4%)
200 mg Lasmiditan QD + Probe Drug Cocktail (Cohort 1)	0/27 (0%)	0/27 (0%)	4/27 (14.8%)
Placebo QD (Cohort 1)	0/12 (0%)	0/12 (0%)	5/12 (41.7%)
Placebo QD + Probe Drug Cocktail (Cohort 1)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
400 mg Lasmiditan QD (Cohort 2)	0/15 (0%)	0/15 (0%)	5/15 (33.3%)
Placebo QD (Cohort 2)	0/15 (0%)	0/15 (0%)	4/15 (26.7%)

Most frequent other events

Showing 10 of 26

Most frequent other events
Event	Probe Drug Cocktail (Cohort 1)	200 mg Lasmiditan QD (Cohort 1)	200 mg Lasmiditan QD + Probe Drug Cocktail (Cohort 1)	Placebo QD (Cohort 1)	Placebo QD + Probe Drug Cocktail (Cohort 1)	400 mg Lasmiditan QD (Cohort 2)	Placebo QD (Cohort 2)
DizzinessNervous system disorders	0/40	6/28	2/27	0/12	0/11	3/15	0/15
FatigueGeneral disorders	0/40	4/28	0/27	0/12	0/11	0/15	0/15
Euphoric moodPsychiatric disorders	0/40	1/28	0/27	0/12	0/11	2/15	0/15
ParaesthesiaNervous system disorders	0/40	0/28	0/27	0/12	1/11	0/15	0/15
Eye painEye disorders	0/40	1/28	0/27	1/12	0/11	0/15	0/15
FolliculitisInfections and infestations	0/40	0/28	0/27	1/12	0/11	0/15	0/15
Wrong technique in product usage processInjury, poisoning and procedural complications	0/40	0/28	0/27	1/12	0/11	0/15	0/15
Decreased appetiteMetabolism and nutrition disorders	0/40	0/28	0/27	1/12	0/11	0/15	0/15
HeadacheNervous system disorders	0/40	0/28	0/27	1/12	0/11	1/15	1/15
NervousnessPsychiatric disorders	0/40	0/28	0/27	1/12	0/11	0/15	0/15

Baseline characteristics

All participants who received at least 1 dose of study drug

Age, Continuous
Age, Continuous(years)	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)	Total
Mean	42.8 ± 11.9	42.9 ± 12.3	39.5 ± 11.4	36.9 ± 9.7	40.9 ± 11.5

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)	Total
Female	6	12	6	6	30
Male	6	16	9	9	40

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)	Total
Hispanic or Latino	8	10	5	8	31
Not Hispanic or Latino	4	18	10	7	39
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	4	13	7	7	31
White	8	15	8	7	38
More than one race	0	0	0	1	1
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)	Total
United States	12	28	15	15	70

Weight
Weight(kilograms (kg))	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)	Total
Mean	74.78 ± 13.14	81.92 ± 13.72	74.13 ± 11.04	78.95 ± 14.67	78.39 ± 13.45

Body Mass Index (BMI)
Body Mass Index (BMI)(kilograms per meter squared)	Cohort 1a (Placebo+Probe Drug Cocktail)	Cohort 1b (200 mg Lasmiditan+Probe Drug Cocktail)	Cohort 2a (Placebo)	Cohort 2b (400 mg Lasmiditan)	Total
Mean	27.17 ± 2.54	28.18 ± 3.51	25.87 ± 3.32	27.14 ± 3.88	27.29 ± 3.45

Study locations

1 site

Covance Daytona Beach
Daytona Beach, Florida 32117, United States

References and documents

Study documents

Study protocol · Aug 31, 2017
Statistical analysis plan · Sep 11, 2017

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03252015
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Aug 16, 2017
Start date: Aug 15, 2017
Primary completion: Jan 2, 2018
Completion: Jan 2, 2018
Results posted: Jan 10, 2020
Last update: Jan 10, 2020

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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