A Study of Lasmiditan in Participants With Migraine

NCT03247790 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16854H8H-MC-LAHC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (2)

• 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

• PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period

  PK: AUC(0-∞) 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 Outcomes (2)

• PK: Maximum Observed Drug Concentration (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

• PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) 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

Study Arms (2)

Lasmiditan (Period 1)

EXPERIMENTAL

200 mg Lasmiditan tablet given once orally during migraine attack.

Drug: Lasmiditan

Lasmiditan (Period 2)

EXPERIMENTAL

200 mg Lasmiditan tablet given once orally during inter-ictal period.

Drug: Lasmiditan

Interventions

Lasmiditan DRUG

Administered orally

Also known as: LY573144

Lasmiditan (Period 1); Lasmiditan (Period 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

eStudySite

San Diego, California, 92120, United States

Location

AGA Clinical Trials

Hialeah, Florida, 33012, United States

Location

Meridien Research Inc.

Tampa, Florida, 33634, United States

Location

Related Links

• A Study of Lasmiditan in Participants With Migraine

MeSH Terms

Conditions

Migraine Disorders

Interventions

lasmiditan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, open-label study with 2 study periods.

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 14, 2017
• Study Start: August 16, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2018-01

Locations

US (3)