A Study of Lasmiditan in Participants With Migraine

Migraine Disorders Clinical Trial

Official title:

An Open-Label, Two-Period Study to Evaluate the Pharmacokinetics of Lasmiditan in Migraineurs During Acute Migraine Attacks and During Inter-Ictal Periods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247790
• Other study ID #: 16854
• Secondary ID: H8H-MC-LAHC
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: January 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it during an acute migraine attack and also during the time between acute migraine attacks.

Information about any side effects that may occur will also be collected.

This study includes two study periods. Each study period requires an overnight stay in the Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up to two outpatient appointments. This study will last approximately 5-6 weeks (not including screening).

Follow-up is required four to seven days after last dose of investigational drug. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females with history of migraine with or without aura, as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 and 1.2) (ICHD-3 beta, Cephalalgia 2013), for at least 1 year, based on medical history

• Have a body mass index (BMI) of 18.0 to 40.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

Exclusion Criteria:

• Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan

• Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed

• Have an abnormal blood pressure, defined as systolic blood pressure less than or equal to (=) 90 or greater than (>) 155 millimeters of mercury (mmHg) or diastolic blood pressure = to 50 or >95 mmHg

• Have clinically significant electrocardiogram (ECG) findings, including a QT interval corrected for heart rate using QT interval corrected for heart rate using Fridericia's formula (QTcF) value >450 milliseconds (ms) (males) or >470 ms (females), clinically significant bradycardia, cardiac block, or bradyarrhythmias

• Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, major depressive disorder)

• Have a history of gastrointestinal surgery, or a history of or current irritable bowel syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable

• Have used or intend to use any migraine prevention treatments (including, but not limited to, propranolol or topiramate) within 30 days prior to dosing and until the follow-up visit

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Lasmiditan
Administered orally

Locations

Country	Name	City	State
United States	AGA Clinical Trials	Hialeah	Florida
United States	eStudySite	San Diego	California
United States	Meridien Research Inc.	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period	PK: Cmax of Lasmiditan in Each Period.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose
Primary	PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Lasmiditan in Each Period	PK: AUC(0-8) of Lasmiditan in Each Period.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose
Secondary	PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period	PK: Cmax of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose
Secondary	PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period	PK: AUC(0-8) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose

External Links

•   A Study of Lasmiditan in Participants With Migraine