NCT03310411

A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants

Completed Phase 1 Results posted Last updated 27 November 2019

What this trial tests

Phase 1 trial testing Lasmiditan in Healthy in 40 participants. Completed in 23 December 2017.

Timeline

17 October 2017

Primary endpoint
23 December 2017

23 December 2017

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	40
Start date	17 October 2017
Primary completion	23 December 2017
Estimated completion	23 December 2017
Sites	1 location across United States

Drugs / interventions tested

• Lasmiditan (LASMIDITAN) — full drug profile →
• Sumatriptan (SUMATRIPTAN) — full drug profile →
• Placebo for Lasmiditan — full drug profile →
• Placebo for Sumatriptan — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacodynamics (PD): Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) Primary · Baseline (Day 1), Day 2

Systolic Blood Pressure (SBP) was measured by using a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least squares (LS) mean peak changes from baseline were calculated using a linear mixed-effects model with baseli

Group	Value	95% CI
200 mg Lasmiditan + 100 mg Sumatriptan (A):	13.81	11.83 – 15.79
200 mg Lasmiditan + Placebo (B)	12.17	10.47 – 13.87
100 mg Sumatriptan + Placebo (C)	13.63	11.65 – 15.61
Placebo + Placebo (D)	11.42	9.74 – 13.09

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan and Sumatriptan Secondary · Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 , 24 ,36 and 48 hours(h) postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose

PK: Cmax of Lasmiditan and Sumatriptan was evaluated.

Group	Value	95% CI
200 mg Lasmiditan + 100 mg Sumatriptan (A):Analyte: Lasmiditan	304	± 39
200 mg Lasmiditan + Placebo (B): Analyte: Lasmiditan	328	± 32
200 mg Lasmiditan +100 mg Sumatriptan (A):Analyte: Sumatriptan	56.8	± 36
100 mg Sumatriptan + Placebo (C): Analyte: Sumatriptan	50.7	± 42

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0 ∞]) of Lasmiditan and Sumatriptan Secondary · Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12, 24 ,36 and 48 h postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose

PK: AUC(0 ∞) of Lasmiditan and Sumatriptan was evaluated.

Group	Value	95% CI
200mg Lasmiditan + 100mg Sumatriptan (A): Analyte: Lasmiditan	2110	± 37
200 mg Lasmiditan + Placebo (B): Analyte: Lasmiditan	2170	± 33
200 mg Lasmiditan +100 mg Sumatriptan (A):Analyte: Sumatriptan	253	± 28
100 mg Sumatriptan + Placebo (C): Analyte: Sumatriptan	240	± 29

Adverse events — posted to ClinicalTrials.gov

Time frame: Up To 36 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

200 mg Lasmiditan + 100 mg Sumatriptan (A)

Serious: 0/39 (0%)

Deaths: 0/39

200 mg Lasmiditan + Placebo (B)

Serious: 0/39 (0%)

Deaths: 0/39

100 mg Sumatriptan + Placebo (C)

Serious: 0/39 (0%)

Deaths: 0/39

Placebo + Placebo (D)

Serious: 0/40 (0%)

Deaths: 0/40

Other adverse events (3 terms — click to expand)

Reaction	System	200 mg Lasmiditan + 100 mg…	200 mg Lasmiditan + Placeb…	100 mg Sumatriptan + Place…	Placebo + Placebo (D)
Dizziness	Nervous system disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03310411 adverse events section.

Sponsor's own description

The purpose of this study is to assess whether taking lasmiditan and sumatriptan together will have any additional effects on heart rate and blood pressure compared to taking lasmiditan and sumatriptan individually. This study will also look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it when these two drugs are taken together.

This study will last about 21 days, not including the screening. Participants will spend 16 days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is required within 28 days prior to the start of the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Serotonin receptor agonists in the acute treatment of migraine: a review on their therapeutic potential.
   Negro A, Koverech A, Martelletti P. · · 2018 · cited 57× · PMID 29563831 · DOI 10.2147/jpr.s132833