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Completed

NCT Number: NCT05176314

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

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.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS Bio-Kinetic Clinical Applications, Springfield, Missouri, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

Administered Orally.

Pirtobrutinib

Drug

Administered Orally.

Other names: LY3527727

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin

    Time frame: Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose.

    PK: Cmax of Rosuvastatin

  2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin

    Time frame: Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose.

    PK: AUC(0-inf) of Rosuvastatin

Sponsors and collaborators

Lead sponsor

Loxo Oncology, Inc.

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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