Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants

Completed · Phase 1

Conditions studied: Healthy, Hepatic Insufficiency

In brief

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 and healthy participants. The side effects and tolerability of pirtobrutinib will also be evaluated. Participation could last about 46 days.

Key facts

Study ID

NCT06190691

Run by

Eli Lilly and Company

People needed

36

Starts

2020-12-18

Expected to finish

2021-12-30

Last updated by the study team

2025-01-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Orange County Research Institute — Anaheim, California, United States
• Orange County Research Center — Tustin, California, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Clinical Pharmacology of Miami — Miami, Florida, United States
• Advanced Pharma Clinical Research — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• The Texas Liver Institute — San Antonio, Texas, United States
• Pinnacle Clinical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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