MigrainePhase 1NCT03076970

Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Participants

A Phase 1 study testing lasmiditan 200 mg and Sumatriptan in people with Migraine, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a randomized, double-blind, three-period, cross-over study to investigate the effect of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of lasmiditan 200 mg. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Migraine
What is being tested?: lasmiditan 200 mg and Sumatriptan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 21 Mar 2017to 13 Apr 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female aged 18-60 years, inclusive.
Able and willing to give written informed consent.
Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²), inclusive.
Participants must be able to refrain from consuming xanthine, quinine and caffeine containing beverages, and must refrain from prolonged intensive physical exercise during the study (from 72 hours prior to dosing until the end of study).
Women must be:
not pregnant

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not breast-feeding
not planning to become pregnant during the study
All females must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in on Day -1 of each period. All women must agree to use an adequate method of contraception during the study and for 30 days following the end-of-study.
Male participants must agree to utilize a highly effective method of contraception (condom plus spermicide) during heterosexual intercourse from clinic admission until 30 days following the end of study.
Male participants must agree to refrain from sperm donation from clinic admission until at least 30 days following the end of study.
Participants must be able to swallow multiple pills simultaneously.
Participants must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.

Who cannot join

Any medical condition, clinical laboratory test or other reason which in the judgment of the Investigator or designee makes the participant unsuitable for the study.
Any clinically significant abnormalities (as determined by the Principal Investigator or designee) in hematology, blood chemistry and/or urinalysis lab tests at screening or at Period 1 D-1.
Known hypersensitivity to lasmiditan, sumatriptan (Imitrex), or to any excipient of lasmiditan or sumatriptan (Imitrex) oral tablets.
Use of any prescription medication, including monoamine oxidase A (MAO-A) inhibitors and other drugs associated with serotonin syndrome, within 14 days prior to dosing (except hormonal contraceptives) except for 5-HT1 (serotonin) agonists and selective serotonin reuptake inhibitors.
History, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including but not limited to angina pectoris, myocardial infarction, silent myocardial ischemia (Ischemic cardiac syndromes), stroke, transient ischemic attacks (cerebrovascular syndromes), and ischemic bowel disease (peripheral vascular disease).
History, symptoms, or signs of vasospastic coronary artery disease.

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History, symptoms, or signs of arrhythmia or Wolff Parkinson White (WPW) syndrome that could affect the participant's safety in the opinion of the Investigator or designee.
History, symptoms, or signs of severe hepatic impairment.
History, symptoms, or signs of diabetes.
History within the previous 3 years or current evidence of abuse (according to Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition [DSM-IV] criteria) of any drug, prescription or illicit, or alcohol; a positive urine screen for drugs of abuse or breathalyzer alcohol test.
Positive urinary test for drugs of abuse and/or alcohol breath test at Screening and/or at check-in on Day -1 of each Period. Cotinine will be included at screening only.
History of orthostatic hypotension with or without syncope.
Supine systolic blood pressure (BP) > 135 millimeters of mercury (mmHg), diastolic BP > 85 mm Hg, respiratory rate >20 breaths per minute, pulse >90 beats per minute, or temperature >37.5º at Screening. Low values on any vital sign measurement will be assessed at the discretion of the Investigator or designee. For orthostatic vital signs, any decrease in systolic and/or diastolic blood pressure great than 20 mmHg. Any other changes will be assessed at the discretion of the Investigator or designee.
Electrocardiogram (ECG) changes including QT interval prolongation and congenital long QT syndrome.
Electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, or other medicinal products that lead to QT prolongation.
Any clinically significant alanine aminotransferase (ALT), alkaline phosphatase (AP), aspartate aminotransferase (AST), or bilirubin abnormalities judged by the Investigator or designee at Screening.
Treatment with centrally active drugs or those affecting peripheral cholinergic transmission within 3 months of study entry.
Consumption of grapefruit, grapefruit juice, Seville oranges, Seville orange juice, or beverages containing any of these juices or consumption of members of the mustard green family (including kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard (i.e. seeds, greens, spice or the condiment)) within 72 hours of dosing.
Tobacco or nicotine users except participants who stopped using tobacco or nicotine 1 year or more before signing the informed consent.
Participant is at imminent risk of suicide or had a suicide attempt within 6 months prior to screening .
Participation in any clinical trial of an experimental drug or device in the previous 30 days.
Positive Hepatitis C antibody, Hepatitis B surface antigen, or positive human immunodeficiency virus (HIV) antibody.
Participants who donated plasma in the 7 days or blood in the 3 months - Participants with an inability to communicate well with the Investigator or designee and study staff (i.e., language problem, poor mental development or impaired cerebral function).
Inability to fast or consume the food provided in the study.
Relatives of or staff directly reporting to the Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

SNBL Clinical Pharmacology Unit
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Three Period, Cross-Over Study to Evaluate the Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan (Imitrex) in Healthy Male and Female Subjects

This is a randomized, double-blind, three-period, cross-over study to investigate the effect of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of lasmiditan 200 mg.

Read the detailed description

This is a randomized, double-blind, three-period, cross-over study to investigate the effect of single doses of sumatriptan (Imitrex) 100 mg on the pharmacodynamics of single doses of lasmiditan 200 mg. The study will last approximately 6 weeks including up to 3 weeks for screening and 22 days on study. Screening will be conducted within approximately 21 days of the first dose of study medication. Each dosing period will last 3 days (Day 1, Day 1, and Day 2). A wash-out period of 6 days will take place between each dose. The End of Study Visit (EoS) will take place 5 (+/- 2) days after the third dosing period is completed.

Conditions: Migraine
Being tested: lasmiditan 200 mg, Sumatriptan, matching placebo
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lasmiditan 200 mgDrug
Also called LY573144
drug including single placebo tablet
SumatriptanDrug
drug including single placebo tablet
matching placeboDrug
single oral tablet -given with single lasmiditan tablet and with single sumatriptan tablet.

Study groups in NCT03076970
Study group	Role	What they receive
Lasmiditan 200 mg	Experimental	single oral tablet Receives: Drug: lasmiditan 200 mg; Drug: matching placebo
Sumatriptan 100 mg	Active comparator	single oral tablet Receives: Drug: Sumatriptan; Drug: matching placebo
Combination of lasmiditan and sumatriptan	Experimental	single oral tablet of each Receives: Drug: lasmiditan 200 mg; Drug: Sumatriptan

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Systolic Blood Pressure
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Diastolic Blood Pressure
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Pulse Rate
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Temperature
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Respiratory Rate
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Heart Rate
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) PR Duration
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QRS Duration
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcB - Bazett's Correction Formula
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcF - Fridericia's Correction Formula
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QT Duration
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) RR Duration
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Measured: Pre-dose, 24 hours post-dose
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety assessed from time of consent through end of study. A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the adverse events module of this record.
Measured: Up to 6 weeks

Secondary outcomes (3)

Pharmacokinetics - Cmax
Maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period
Pharmacokinetics - AUC0-t
Area under the plasma concentration versus time curve from time 0 to the time t of the last quantifiable concentration, calculated by means of the mixed log-linear trapezoidal rule of lasmiditan alone compare to lasmiditan in combination with sumatriptan.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period
Pharmacokinetics - Tmax
Time to maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 201713 Apr 2017

First posted10 Mar 2017
Study start21 Mar 2017
Primary completion13 Apr 2017
Study completion13 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03076970
Sponsor's protocol ID: 16885
Other IDs: COL MIG-118, H8H-CD-LAHI
Status last verified: Jan 2018
First submitted: 2 Mar 2017
Last updated: 2 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Recruiting
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Three Period, Cross-Over Study to Evaluate the Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan (Imitrex) in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT03076970
Acronym / sponsor ID: 16885
Conditions: Migraine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: SNBL Clinical Pharmacology Center, Inc., CoLucid Pharmaceuticals
Study start: 21 Mar 2017 (actual)
Primary completion: 13 Apr 2017 (actual)
Study completion: 13 Apr 2017 (actual)
First posted: 10 Mar 2017 (actual)
Results: Posted 2 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomized, double-blind, three-period, cross-over study to investigate the effect of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of lasmiditan 200 mg.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Lasmiditan 200 mg	Experimental	Drug: lasmiditan 200 mg, Drug: matching placebosingle oral tablet
Sumatriptan 100 mg	Active comparator	Drug: Sumatriptan, Drug: matching placebosingle oral tablet
Combination of lasmiditan and sumatriptan	Experimental	Drug: lasmiditan 200 mg, Drug: Sumatriptansingle oral tablet of each

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Male or female aged 18-60 years, inclusive.
Able and willing to give written informed consent.
Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²), inclusive.
Participants must be able to refrain from consuming xanthine, quinine and caffeine containing beverages, and must refrain from prolonged intensive physical exercise during the study (from 72 hours prior to dosing until the end of study).
Women must be:

Key exclusion criteria (25 listed)

Any medical condition, clinical laboratory test or other reason which in the judgment of the Investigator or designee makes the participant unsuitable for the study.
Any clinically significant abnormalities (as determined by the Principal Investigator or designee) in hematology, blood chemistry and/or urinalysis lab tests at screening or at Period 1 D-1.
Known hypersensitivity to lasmiditan, sumatriptan (Imitrex), or to any excipient of lasmiditan or sumatriptan (Imitrex) oral tablets.
Use of any prescription medication, including monoamine oxidase A (MAO-A) inhibitors and other drugs associated with serotonin syndrome, within 14 days prior to dosing (except hormonal contraceptives) except for 5-HT1 (serotonin) agonists and selective serotonin reuptake inhibitors.
History, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including but not limited to angina pectoris, myocardial infarction, silent myocardial ischemia (Ischemic cardiac syndromes), stroke, transient ischemic attacks (cerebrovascular syndromes), and ischemic bowel disease (peripheral vascular disease).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lasmiditan 200 mgAlso: LY573144drug including single placebo tablet	Drug	Combination of lasmiditan and sumatriptan, Lasmiditan 200 mg
Sumatriptandrug including single placebo tablet	Drug	Combination of lasmiditan and sumatriptan, Sumatriptan 100 mg
matching placebosingle oral tablet -given with single lasmiditan tablet and with single sumatriptan tablet.	Drug	Lasmiditan 200 mg, Sumatriptan 100 mg

Primary outcome

Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Systolic Blood Pressure
Time frame: Pre-dose, 24 hours post-dose
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Diastolic Blood Pressure
Time frame: Pre-dose, 24 hours post-dose
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Pulse Rate
Time frame: Pre-dose, 24 hours post-dose
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Temperature
Time frame: Pre-dose, 24 hours post-dose
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Respiratory Rate
Time frame: Pre-dose, 24 hours post-dose
Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Heart Rate
Time frame: Pre-dose, 24 hours post-dose
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) PR Duration
Time frame: Pre-dose, 24 hours post-dose
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QRS Duration
Time frame: Pre-dose, 24 hours post-dose
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcB - Bazett's Correction Formula
Time frame: Pre-dose, 24 hours post-dose
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcF - Fridericia's Correction Formula
Time frame: Pre-dose, 24 hours post-dose
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QT Duration
Time frame: Pre-dose, 24 hours post-dose
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) RR Duration
Time frame: Pre-dose, 24 hours post-dose
A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 6 weeks
Safety assessed from time of consent through end of study. A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the adverse events module of this record.

3 secondary outcomes

Pharmacokinetics - Cmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period
Pharmacokinetics - AUC0-t
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period
Pharmacokinetics - Tmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period

Results and safety

Results posted to the registry on 2 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence ABC	7	7
Sequence ACB	7	7
Sequence BCA	7	7
Sequence BAC	7	7
Sequence CAB	7	7
Sequence CBA	7	7

Primary outcome: Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Systolic Blood Pressure

Time frame: Pre-dose, 24 hours post-dose. Mean (Standard Deviation). Unit: millimeters of mercury (mmHg)

Measure	Lasmiditan 200 mg n = 41	Sumatriptan 100 mg n = 40	Combination of Lasmiditan and Sumatriptan n = 42
Value	0.6 (7.03)	-2.3 (12.88)	-0.1 (8.22)

Population analysed: All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.

Primary outcome: Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Diastolic Blood Pressure

Time frame: Pre-dose, 24 hours post-dose. Mean (Standard Deviation). Unit: mmHg

Measure	Lasmiditan 200 mg n = 41	Sumatriptan 100 mg n = 40	Combination of Lasmiditan and Sumatriptan n = 42
Value	-1.3 (6.33)	-1.1 (7.53)	0.6 (6.14)

Population analysed: All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.

Primary outcome: Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Pulse Rate

Time frame: Pre-dose, 24 hours post-dose. Mean (Standard Deviation). Unit: beats/min

Measure	Lasmiditan 200 mg n = 41	Sumatriptan 100 mg n = 40	Combination of Lasmiditan and Sumatriptan n = 42
Value	-2.5 (9.75)	-1.0 (9.51)	1.8 (7.46)

Population analysed: All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.

Primary outcome: Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Temperature

Time frame: Pre-dose, 24 hours post-dose. Mean (Standard Deviation). Unit: Celsius (C)

Measure	Lasmiditan 200 mg n = 41	Sumatriptan 100 mg n = 40	Combination of Lasmiditan and Sumatriptan n = 42
Value	0.0 (0.51)	-0.0 (0.41)	-0.1 (0.54)

Population analysed: All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lasmiditan 200 mg	0 of 41 (0%)	24 of 41 (58.5%)	0 of 41
Sumatriptan 100 mg	0 of 40 (0%)	16 of 40 (40%)	0 of 40
Combination of Lasmiditan and Sumatriptan	0 of 42 (0%)	28 of 42 (66.7%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lasmiditan 200 mg and Sumatriptan in people with Migraine, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Systolic Blood Pressure (time frame: Pre-dose, 24 hours post-dose). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03076970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.