A Study of Multiple Doses of Lasmiditan in Healthy Participants

NCT03252015 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16859H8H-MC-LAHE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it. When drugs are taken together, one or all of the drugs used in combination may be affected. This study will also evaluate the concentrations in the blood of a probe drug cocktail taken alone and in combination with lasmiditan. Information about any side effects that may occur will also be collected. The study has two parts. Participants will only enroll in one part. This study will last about 25 days for group 1 and 22 days for group 2, not including screening. 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

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.

  Baseline through 14 days after last administration of study drug

Secondary Outcomes (10)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1

  Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7

  Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose

• Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1

  Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose

• Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7

  Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose

• Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score

  PreDose Day 7 and Day 21

Study Arms (5)

Probe Drug Cocktail (Cohort 1a)

EXPERIMENTAL

Probe Drug Cocktail administered orally on Day -3.

Drug: Probe Drug Cocktail

200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)

EXPERIMENTAL

200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.

Drug: Probe Drug Cocktail; Drug: Lasmiditan

Placebo+Probe Drug Cocktail (Cohort 1b)

PLACEBO COMPARATOR

Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.

Drug: Probe Drug Cocktail; Drug: Placebo

400 mg Lasmiditan (Cohort 2a)

EXPERIMENTAL

400 mg lasmiditan administered orally for 7 days.

Drug: Lasmiditan

Placebo (Cohort 2b)

EXPERIMENTAL

Placebo administered orally for 7 days.

Drug: Placebo

Interventions

Probe Drug Cocktail DRUG

Administered orally

200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1); Placebo+Probe Drug Cocktail (Cohort 1b); Probe Drug Cocktail (Cohort 1a)

Lasmiditan DRUG

Administered orally

Also known as: LY573144

200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1); 400 mg Lasmiditan (Cohort 2a)

Placebo DRUG

Administered orally

Placebo (Cohort 2b); Placebo+Probe Drug Cocktail (Cohort 1b)

Eligibility Criteria

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

You may qualify if:

• Healthy males or females, as determined by medical history and physical examination
• Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

You may not qualify if:

• Have participated, within the last 30 days, in a clinical study involving an Investigational Product (IP)
• Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan
• Have clinically significant abnormality in the 12-lead ECG, including corrected QT interval (QTc) with Fridericia's correction (QTcF) greater than (\>) 450 milliseconds (ms) for men or \>470 ms for women or any abnormality that in the opinion of the investigator increases the risk of participating in the study (not limited to significant bradycardia or heart block)
• History of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression), have a recent history of a suicide attempt (30 days within screening visit and any time between screening visit and baseline); or are clinically judged by the investigator to be at risk for suicide
• History of hypoglycemia
• Known history of glucose-6-phosphate dehydrogenase deficiency
• Are taking a concomitant medication or a dietary substance that affects cytochrome P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

lasmiditan

Results Point of Contact

• Title: Cheif 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: Yes

Study Design

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

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 16, 2017
• Study Start: August 15, 2017
• Primary Completion: January 2, 2018
• Study Completion: January 2, 2018
• Last Updated: January 10, 2020
• Results First Posted: January 10, 2020

Record last verified: 2018-03

Locations

US (1)