A Study of Lasmiditan on the Heart in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lasmiditan; Drug: Moxifloxacin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03465436

COL-MIG-105 (Other Identifier)

16900

2011-003229-88 (EudraCT Number)

H8H-CD-LAHP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

• Participant is not able to understand and comply with study requirements, instructions and study restrictions

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

56 participants in 4 patient groups, including a placebo group

100 milligrams (mg) Lasmiditan

Experimental group

Description:

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

Treatment:

Drug: Lasmiditan

Drug: Lasmiditan

400 mg Lasmiditan

Experimental group

Description:

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

Treatment:

Drug: Lasmiditan

Drug: Lasmiditan

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin