A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to determine the effect of pirtobrutinib on the levels of rosuvastatin in the blood stream in healthy participants. This study will also evaluate the safety and tolerability of rosuvastatin when administered in combination with pirtobrutinib in healthy participants. This study will last up to approximately 26 days excluding screening period.

Official Title
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A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single and Multiple Doses of Pirtobrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Pirtobrutinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs. Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per meter squared (kg/m²) and a body weight of at least 50 kg. Males, or female participants who are not of childbearing potential. Exclusion Criteria: Have known allergies to pirtobrutinib or rosuvastatin, related compounds, or any components of the formulation. Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator. Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorder or surgery (including cholecystectomy) capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data. Have used or intend to use prescription or nonprescription medication (including dietary supplements, vitamins, and/or herbal medications), or modulators of CYP3A4 or BCRP within 7 days prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study. Have c.34AA, c.421AA, or c.34GA/421CA genotypes of ABCG2 as determined through genotyping. Have c.521TC and c/521CC genotypes of SLCO1B1 as determined by genotyping.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Basic Science
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin + Pirtobrutinib<br>Rosuvastatin administered orally on day 1 followed by rosuvastatin administered with pirtobrutinib on day 6 orally. Pirtobrutinib alone administered orally from days 7 to 12 followed by rosuvastatin administered with a single dose of pirtobrutinib on day 13. Pirtobrutinib alone administered from days 14 to17. | Drug: Rosuvastatin<br>* Administered Orally.<br>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): Maximum Concentration (Cmax) of Rosuvastatin | PK: Cmax of Rosuvastatin | Pre-dose up to 120 hours post-dose | 
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin | PK: AUC(0-inf) of Rosuvastatin | Pre-dose up to 120 hours post-dose |