Food-Effect Study in Healthy Participants | NCT02233296

NCT02233296

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
H8H-CD-LAHR	Other Identifier	Eli Lilly and Company
COL MIG-104	Other Identifier	CoLucid Pharmaceuticals

Status Module

Name	Class
CoLucid Pharmaceuticals	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Lasmiditan	Drug	2 discrete doses separated by 6 days.	Group A Group B

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

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.

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
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

Arm/Group Information

ID	Title	Description
FG000	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 Lasmiditan: 2 discrete doses separated by 6 days.
FG001	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. Lasmiditan: 2 discrete doses separated by 6 days.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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 Lasmiditan: 2 discrete doses separated by 6 days.
BG001	Group B

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

all participants with evaluable PK data according to the following criteria:

completion of both treatment regimens,
availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),
absence of any important protocol deviation that would have rendered the data incomparable between treatments

Posted

Mean

Standard Deviation

ng/mL

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)

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fed Condition (n=30)	Participants were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while participant was in fed condition are considered equally.

OG000	Fed Condition	Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
OG001	Fasted Condition	Participants were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.