Status:
COMPLETED
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Loxo Oncology, Inc.
Conditions:
Healthy
Hepatic Insufficiency
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function ...
Eligibility Criteria
Inclusion
- Participants with mild, moderate or severe hepatic impairment and healthy participants with normal hepatic function
- Males and females of non-childbearing potential.
- Within body mass index (BMI) range 18.5 to 40.0 kilograms per square meter (kg/m²).
- Participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), and clinical laboratory tests, as determined by the Investigator (or designee).
- Able to comply with all study procedures, including the 8-night stay at the Clinical Research Unit and follow-up phone call.
Exclusion
- History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
- pancreatitis
- peptic ulcer disease
- intestinal malabsorption
- gastric reduction surgery
- history or presence of clinically significant cardiovascular disease.
- Participants with out-of-range, at-rest vital signs.
- Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
- Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
- Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
- Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial.
- History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
- Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
- Receipt of blood products within 2 months prior to Check-in (Day -1).
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator).
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06190691
Start Date
December 18 2020
End Date
December 30 2021
Last Update
January 9 2025
Active Locations (8)
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1
Orange County Research Institute
Anaheim, California, United States, 92801
2
Orange County Research Center
Tustin, California, United States, 92780
3
Riverside Clinical Research
Edgewater, Florida, United States, 32132
4
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014