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

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