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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2021-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Hepatic Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pirtobrutinib (Normal Hepatic Function)

Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally

Pirtobrutinib (Mild Hepatic Impairment)

Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally

Pirtobrutinib (Moderate Hepatic Impairment)

Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally

Pirtobrutinib (Severe Hepatic Impairment)

Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally

Interventions

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Pirtobrutinib

Administered orally

Intervention Type DRUG

Other Intervention Names

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LOXO-305, LY3527727

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

1. pancreatitis
2. peptic ulcer disease
3. intestinal malabsorption
4. gastric reduction surgery
5. 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes