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

NCT ID: NCT06190678

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-06-04

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

Conditions

Healthy; Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Pirtobrutinib (Normal Renal Function)

Participants with normal renal function (eGFR \>= 90 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1.

Group Type: EXPERIMENTAL

Pirtobrutinib

Intervention Type: DRUG

Administered orally

Pirtobrutinib (Severe Renal Impairment)

Participants with severe renal impairment (eGFR: \< 30 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 mg administered orally on Day 1.

Group Type: EXPERIMENTAL

Pirtobrutinib

Intervention Type: DRUG

Administered orally

Interventions

Pirtobrutinib

Administered orally

Intervention Type: DRUG

Other Intervention Names

LOXO-305, LY3527727

Eligibility Criteria

Inclusion Criteria

• Participants with impaired renal function [estimated Glomerular Filtration Rate (eGFR): < 90 milliliters per minute (mL/min) per 1.73 square meters (m2)] and healthy participants with normal renal function [(eGFR: ≥ 90 mL/min/1.73 m2)].
• 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), or 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. liver disease

2. pancreatitis

3. peptic ulcer disease

4. intestinal malabsorption

5. gastric reduction surgery

6. 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 of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loxo Oncology, Inc.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renée Ward, MD, PhD

Role: STUDY_DIRECTOR

Loxo Oncology

Locations

Orange County Research Institute

Anaheim, California, United States

Riverside Clinical Research

Edgewater, Florida, United States

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Prism Research

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J2N-OX-JZNG

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-BTK-20013

Identifier Type: -

Identifier Source: org_study_id