A Study of Lasmiditan on the Heart in Healthy Participants

NCT03465436 | Completed Phase 1 Results FDA Drug

• 4 other identifiers: 16900H8H-CD-LAHPCOL-MIG-1052011-003229-88
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. The study lasted a maximum of 46 days for each participant, not including screening.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin

  The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.

  Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

Secondary Outcomes (7)

• Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin

  Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

• Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin

  Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

• Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin

  Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

• Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin

  Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

• Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds

  Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

Study Arms (4)

100 milligrams (mg) Lasmiditan

EXPERIMENTAL

A single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods.

Drug: Lasmiditan

400 mg Lasmiditan

EXPERIMENTAL

A single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods.

Drug: Lasmiditan

Placebo

PLACEBO COMPARATOR

Placebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods.

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods.

Drug: Moxifloxacin

Interventions

Lasmiditan DRUG

100 mg administered orally (PO)

Also known as: LY573144

100 milligrams (mg) Lasmiditan

Placebo DRUG

Placebo administered for lasmiditan or moxifloxacin

Placebo

Moxifloxacin DRUG

400 mg moxifloxacin administered PO

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)
• In good physical and mental health as determined by the following:
• Complete medical history
• Complete physical examination
• Vital signs including blood pressure (supine and standing), heart rate (supine and standing), respiratory rate, and temperature
• Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for arrhythmia monitoring
• Clinical laboratory tests

You may not qualify if:

• Any of the following cardiac abnormalities on safety screening ECG:
• QTcF interval \>430 milliseconds (ms) for males, \>450 ms for females
• Unusual T wave morphology or flattened low voltage T waves
• PR interval \>240 ms or \<110 ms
• Second-degree or third-degree atrioventricular block
• ECG evidence of complete left or right bundle branch block
• Intraventricular conduction delay or QRS duration \>110 ms
• Supine resting heart rate \<45 beats per minute (bpm) or \>90 bpm
• Pathological Q-waves
• Evidence of ventricular pre-excitation
• Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
• Participants with a family history of Long QT syndrome
• History of allergic hypersensitivity to lasmiditan or any component of the formulations
• History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
• Participants with a history of postural hypotension or fainting

Sponsors & Collaborators

• Eli Lilly and Company: lead
• CoLucid Pharmaceuticals: collaborator

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

lasmiditan; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 14, 2018
• Study Start: September 16, 2011
• Primary Completion: December 20, 2011
• Study Completion: December 20, 2011
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

DE (1)