A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants

NCT03310411 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16926H8H-MC-LAHU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether taking lasmiditan and sumatriptan together will have any additional effects on heart rate and blood pressure compared to taking lasmiditan and sumatriptan individually. This study will also look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it when these two drugs are taken together. This study will last about 21 days, not including the screening. Participants will spend 16 days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is required within 28 days prior to the start of the study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamics (PD): Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP)

  Systolic Blood Pressure (SBP) was measured by using a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least squares (LS) mean peak changes from baseline were calculated using a linear mixed-effects model with baseline, treatment, period, and sequence as fixed effects and participant as a random effect.

  Baseline (Day 1), Day 2

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan and Sumatriptan

  Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 , 24 ,36 and 48 hours(h) postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0 ∞]) of Lasmiditan and Sumatriptan

  Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12, 24 ,36 and 48 h postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose

Study Arms (4)

Lasmiditan + Sumatriptan (A)

EXPERIMENTAL

Single oral dose of 200 milligram (mg) lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet in one of four treatment periods.

Drug: Lasmiditan; Drug: Sumatriptan

Lasmiditan + Placebo (B)

EXPERIMENTAL

Single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet in one of four treatment periods.

Drug: Lasmiditan; Drug: Placebo for Sumatriptan

Sumatriptan + Placebo (C)

ACTIVE COMPARATOR

Single oral dose of 100 mg sumatriptan tablet and single oral dose of placebo tablet in one of four treatment periods.

Drug: Sumatriptan; Drug: Placebo for Lasmiditan

Placebo + Placebo (D)

PLACEBO COMPARATOR

Oral doses of placebo tablets in one of four treatment periods.

Drug: Placebo for Lasmiditan; Drug: Placebo for Sumatriptan

Interventions

Lasmiditan DRUG

Administered orally

Also known as: LY573144

Lasmiditan + Placebo (B); Lasmiditan + Sumatriptan (A)

Sumatriptan DRUG

Administered orally

Lasmiditan + Sumatriptan (A); Sumatriptan + Placebo (C)

Placebo for Lasmiditan DRUG

Administered orally

Placebo + Placebo (D); Sumatriptan + Placebo (C)

Placebo for Sumatriptan DRUG

Administered orally

Lasmiditan + Placebo (B); Placebo + Placebo (D)

Eligibility Criteria

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

You may qualify if:

• Are overtly healthy males or females, as determined by medical history and physical examination
• Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

You may not qualify if:

• Have known allergies to Lasmiditan, Sumatriptan, related compounds, or any components of the formulations of Lasmiditan and Sumatriptan
• Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias
• Have a history, signs, or symptoms of arrhythmia or Wolff Parkinson White syndrome that could affect the participant's safety
• Have an estimated glomerular filtration rate (eGFR) of less than (\<) 60 milliliter per minute (mL/min) per 1.73 m²
• Have a resting systolic blood pressure (SBP) greater than (\>) 135 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) \>85 mmHg at screening
• Have a supine pulse rate (PR) of \<50 or \>90 beats per minute (bpm) at screening
• Have a history, signs, or symptoms of vasospastic coronary artery disease
• Have known or ongoing neuropsychiatric disorders (for example, manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator
• Use of monoamine oxidase-A inhibitors and other drugs associated with serotonin within the 3 months prior to the first dosing occasion

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

lasmiditan; Sumatriptan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; 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: OTHER
• 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: October 11, 2017
• First Posted: October 16, 2017
• Study Start: October 17, 2017
• Primary Completion: December 23, 2017
• Study Completion: December 23, 2017
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2018-01

Locations

US (1)