A Study of the Effect of Food on Pirtobrutinib (LOXO-305) in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to conduct blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib (LOXO-305) after meals and on an empty stomach. The study will also evaluate the safety and tolerability of pirtobrutinib (LOXO-305). Participants will stay in this study for up to 53 days (screening through follow-up call).

Official Title
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A Phase I, Open-Label, Randomized, 2-Way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Pirtobrutinib (LOXO-305) in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pirtobrutinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive at Screening Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator Female participants of non-childbearing potential and male participants who follow standard contraceptive methods Must have comply with all study procedures, including the 15-night stay at the Clinical Research Unit (CRU) and follow-up phone call Exclusion Criteria: History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening. Positive polymerase chain reaction (PCR) test for COVID-19 at Screening Known ongoing alcohol and/or drug abuse within 2 years prior to Screening History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) Have previously received pirtobrutinib (LOXO-305) in any other study investigating pirtobrutinib (LOXO-305), within 30 days prior to Day 1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pirtobrutinib (Fasting condition)<br>A single oral dose of pirtobrutinib will be administered under fasted conditions. | Drug: Pirtobrutinib<br>* Administered orally.<br>* Other names: LY3527727;|
| Experimental: Pirtobrutinib (High-fat breakfast)<br>A single oral dose of pirtobrutinib will be administered under fed conditions. There will be a washout period of 7 days between fasted and fed conditions. | Drug: Pirtobrutinib<br>* Administered orally.<br>* Other names: LY3527727;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib | PK: AUC0-24 of Pirtobrutinib | Pre-dose up to 24 hours post-dose on Days 1 and 8 | 
| PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib | PK: AUC0-t of Pirtobrutinib | Pre-dose up to 168 hours post-dose on Days 1 and 8 | 
| PK: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib | PK: AUC0-inf of Pirtobrutinib | Pre-dose up to 168 hours post-dose on Days 1 and 8 | 
| PK: Percentage of AUC0-inf extrapolated (AUC%extrap) of Pirtobrutinib | PK: AUC%extrap of Pirtobrutinib | Pre-dose up to 168 hours post-dose on Days 1 and 8 | 
| PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib | PK: CL/F of Pirtobrutinib | Pre-dose up to 168 hours post-dose on Days 1 and 8 | 
| PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib | PK: t½ of Pirtobrutinib | Pre-dose up to 168 hours post-dose on Days 1 and 8 | 
| PK: Maximum observed concentration (Cmax) of Pirtobrutinib | PK: Cmax of Pirtobrutinib | Pre-dose up to 168 hours post-dose on Days 1 and 8 | 
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax of Pirtobrutinib | Pre-dose up to 168 hours post-dose on Days 1 and 8 | 
| PK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Pirtobrutinib | PK: Lambda Z of Pirtobrutinib | Pre-dose up to 168 hours post-dose on Days 1 and 8 | 
| PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib | PK: Vz/F of Pirtobrutinib | Pre-dose up to 168 hours post-dose on Days 1 and 8 |