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

Completed · Phase 1

Conditions studied: Migraine

In brief

This is a multicenter, open-label, non-randomized, parallel-group, single dose study. 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.

Key facts

Study ID

NCT03040479

Run by

Eli Lilly and Company

People needed

24

Starts

2017-03-14

Expected to finish

2017-07-17

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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) greater than or equal to (≥1) 8.5 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

You may not qualify if…

• 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

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• NOCCR — Knoxville, Kentucky, United States
• Altasciences Company Inc./Algorithme Pharma — Mount Royal, Quebec, Canada

Full record on ClinicalTrials.gov

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