Food-Effect Study in Healthy Participants

NCT02233296 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 16905H8H-CD-LAHRCOL MIG-104
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).

  Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 15 days

• Tolerability

  15 days

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

Lasmiditan DRUG

2 discrete doses separated by 6 days.

Also known as: COL-144, LY573144

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

lasmiditan

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

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: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 8, 2014
• Study Start: January 1, 2015
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 5, 2018
• Results First Posted: August 22, 2016

Record last verified: 2018-04