Food-Effect Study in Healthy Participants

A Randomized Open Label Study to Compare the Bioavailability of Lasmiditan 200 mg Under Fed and Fasted Conditions in Healthy Male and Female Subjects

This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of lasmiditan in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lasmiditan

Detailed Description

An open-label, cross-over, two-period, randomized, sequential study in order to investigate the effect of food on the pharmacokinetics of lasmiditan 200 mg. Two single doses of lasmiditan will be administered with the participants in fed and fasted states.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged 18-50 years.
• Able and willing to give written informed consent.
• Females of child bearing potential must be using or willing to use a medically acceptable method (as defined by the Investigator) of birth control.
• Body mass index (BMI) within 19 and 29.9 kilograms per meter squared (kg/m²).
• No clinically significant abnormalities (as determined by the Principal Investigator) in hematology, blood chemistry and urinalysis lab tests at screening.
• No history of alcohol or drug abuse within the past year. Negative urinary drugs of abuse and alcohol screen determined within 21 days of the start of the study and at check-in Day -1.
• Must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.

Exclusion Criteria:

• Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
• Pregnant or breast-feeding women.
• Use of any prescription within 14 days prior to dosing (except hormonal contraceptives) or over the-counter medications, including vitamins and herbal or dietary supplements within 7 days prior to dosing unless approved by the Investigator and Medical Monitor.
• History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol; a positive urine screen for drugs of abuse or alcohol.
• History of orthostatic hypotension with or without syncope.
• At imminent risk of suicide (positive response to question 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]) or had a suicide attempt within 6 months prior to screening.
• Participation in any clinical trial of an experimental drug or device in the previous 30 days.
• Positive Hepatitis C antibody, Hepatitis B surface antigen, or positive human immunodeficiency virus (HIV) antibody.
• Donated plasma in the 7 days or blood in the 3 months preceding study drug administration.
• Inability to communicate well with the Investigator and study staff (i.e., language problem, poor mental development or impaired cerebral function).
• Inability to fast or consume the food provided in the study.
• Relatives of, or staff directly reporting to, the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2	Drug: Lasmiditan; 2 discrete doses separated by 6 days.; Other Names: LY573144; COL-144
Experimental: Group B; Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.	Drug: Lasmiditan; 2 discrete doses separated by 6 days.; Other Names: LY573144; COL-144

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics - Cmax (ng/mL)	This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).	Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)
Pharmacokinetics - Tmax (Hours)	This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).	Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)
Pharmacokinetics - AUC0-t (ng.h/mL)	This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).	Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)
Pharmacokinetics - AUC0-inf (ng.h/mL)	This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).	Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).	Safety was evaluated in all participants (n=30) under the fasted condition and the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed). The number of unique subjects with an AE and the number of events are provided.	Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 15 days
Tolerability	Tolerability was defined as the number of participants that did not withdraw from the study early due to adverse events.	15 days

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: CoLucid Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Lasmiditan
• Other Study ID Numbers: 16905; H8H-CD-LAHR (Other Identifier: Eli Lilly and Company); COL MIG-104 (Other Identifier: CoLucid Pharmaceuticals)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No