Pharmacokinetic Single Dose Study of Oral Lasmiditan in Participants With Normal and Impaired Hepatic Function

This study will enroll up to 24 participants and will include 2 hepatic impaired participant
groups and one group of control participants with normal hepatic function. Approximately four
participants with mild hepatic impairment will be enrolled first (Group 1). To ensure
participant safety, following dosing of these first four participants, a safety meeting will
take place to review the safety data prior to dosing additional participants. After safety
and pharmacokinetic (PK) results from the first four participants have been reviewed, an
additional four participants with mild hepatic impairment (remainder of Group 1) will be
enrolled concurrently with the moderated hepatic impairment group (Group 2). Thereafter,
matched participants with normal hepatic function (Group 3) will be enrolled. All
participants will participate in one treatment period and will receive a single dose of
lasmiditan in the fasting state.

Inclusion Criteria:

All participants:

- Availability for the entire study period

- Motivated participant and absence of intellectual problems likely to limit the
validity of consent to participate in the study or the compliance with protocol
requirements; ability to cooperate adequately; ability to understand and observe the
instructions of the physician or designee

- Male or female participants

- A female participant of childbearing potential - agrees to use one of the accepted
contraceptive regimens from at least 28 days prior to the drug administration, during
the study and for at least 60 days after the dose.

- A male participant with sexual partners who are pregnant, possibly pregnant, or who
could become pregnant must be unable to procreate, or agrees to use an accepted
contraceptive regimens from first drug administration until 3 months after the drug
administration.

- A male participant agrees to refrain from sperm donation from drug administration
until 90 days after the drug administration

- Participant aged of at least 18 years

- Participant with a body mass index (BMI) ≥18.5 kilogram per square meter (kg/m²)

- Light-, non- or ex-smokers

- Willingness to adhere to the protocol requirements as evidenced by the informed
consent form (ICF)

Participants with Normal Hepatic Function:

- Clinical laboratory values within the laboratory's stated normal range; if not within
this range, these must be without any clinical significance

- Have no clinically significant diseases captured in the medical history or evidence of
clinically significant findings on physical examination and/or clinical laboratory
evaluations (hematology, general biochemistry, endocrinology, electrocardiogram [ECG],
and urinalysis)

- Must match by gender, as well as to the pooled mean values for age (± 10 years) and
weight (± 20%) of participants with hepatic impairment

Hepatic Impaired Participants:

- Considered clinically stable in the opinion of the Investigator

- Presence of mild hepatic impairment (Child-Pugh Class A: 5-6 points) or moderate
hepatic impairment (Child-Pugh Class B: 7-9 points) at screening

Exclusion Criteria:

All Participants:

- Females who are pregnant or are lactating

- History of significant hypersensitivity to lasmiditan or any related products
(including excipients of the formulations) as well as severe hypersensitivity
reactions (like angioedema) to any drugs

- Suicidal tendency, history of or disposition to seizures, state of confusion,
clinically relevant psychiatric diseases

- Participant is 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

- Presence or history of any disorder (including Parkinson disease) that could interfere
with completion of the study based on the opinion of the Principal Investigator

- Any history of tuberculosis and/or prophylaxis for tuberculosis

- Positive results to human immunodeficiency virus antibody/antigen (HIV Ag/Ab) Combo
tests (and HIV I & II screen at Orlando Clinical Research Center site)

- Females who are pregnant according to a positive pregnancy test

- Participants who took lasmiditan in the previous 28 days before Day 1 of this study

- Participants who took an Investigational Product (in another clinical trial) in the
previous 28 days before day 1 of this study

- Participants who have already participated in this clinical study

- Donation of 500 milliliters (mL) or more of blood in the previous 56 days before day 1
of this study

Participants with Normal Hepatic Function:

- Seated pulse rate less than or equal 50 Beats per Minute (bpm) or more than 100 bpm at
screening

- Seated blood pressure below 90/60 millimeters of mercury (mmHg) or higher than 140/90
mmHg at screening

- Presence of significant gastrointestinal, liver, or kidney disease, or any other
conditions known to interfere with the absorption, distribution, metabolism, or
excretion of drugs or known to potentiate or predispose to undesired effects

- History of significant gastrointestinal, liver or kidney disease that may affect drug
bioavailability

- Presence of significant cardiovascular, pulmonary, hematologic, neurological,
psychiatric, endocrine, immunologic or dermatologic disease

- Presence of out-of-range cardiac interval (PR < 110 milliseconds [msec], PR > 220
msec, QRS < 60 msec, QRS >119 msec and QTc > 450 msec for males and > 460 msec for
females) on the screening ECG or other clinically significant ECG abnormalities

- Maintenance therapy with any drug or significant history of drug dependency or alcohol
abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)

- Positive screening of alcohol and/or drugs of abuse

- Positive results to Hepatitis B surface Antigen (HBsAG [B] [hepatitis B]) or Hepatitis
C Virus (HCV [C]) tests

- Any clinically significant illness in the previous 28 days before day 1 of this study

- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450
(CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin,
fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP
enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and
St John's Wort), in the previous 28 days before day 1 of this study

- Participants who donated 50 mL or more of blood in the previous 28 days before day 1
of this study

Hepatic Impaired Participants:

- Seated pulse rate less than 40 bpm or more than 110 bpm at screening

- Seated blood pressure below 90/50 mmHg or higher than 170/100 mmHg at screening

- History of hepatic transplant

- Acute exacerbation of hepatic disease within 14 days of study drug administration

- History or presence, in the opinion of the Investigator, of significant clinically
unstable respiratory, cardiovascular, pulmonary, renal, hematologic, gastrointestinal,
endocrine, immunologic, dermatologic, neurologic, or psychiatric disease

- Have poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c >10%

- Evidence of hepatocellular carcinoma present or acute hepatic disease from infection
or drug toxicity at the time of screening

- Presence of severe encephalopathy

- Presence of surgically-created or transjugular intrahepatic portal systemic shunts

- History of any major surgery within 6 months before Day 1

- History of bariatric surgery or any other gastrointestinal surgery that may induce
malabsorption

- Estimated creatinine clearance by Cockcroft-Gault equation < 40 mL/min/1.73 m² at
screening

- Presence of clinically significant physical, laboratory, or ECG finding that, in the
opinion of the Investigator and/or Sponsor, may interfere with any aspect of study
conduct or interpretation of results

- Participants with acute, unstable, or untreated significant medical conditions.

- Positive screening of alcohol and/or drugs of abuse unless results can be explained by
a prescription medication

- Participants who donated 100 mL or more of blood in the previous 28 days before day 1
of this study