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

Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05176314
Collaborator
Eli Lilly and Company (Industry)
34
Enrollment
2
Locations
1
Arm
2.4
Actual Duration (Months)
17
Patients Per Site
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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
Actual Study Start Date :
Jan 10, 2022
Actual Primary Completion Date :
Mar 23, 2022
Actual Study Completion Date :
Mar 23, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rosuvastatin + Pirtobrutinib

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
Administered Orally.

Drug: Pirtobrutinib
Administered Orally.
Other Names:
  • LY3527727

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin [Pre-dose up to 120 hours 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 [Pre-dose up to 120 hours post-dose]

      PK: AUC(0-inf) of Rosuvastatin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 QPS Bio-Kinetic Clinical Applications Springfield Missouri United States 65802
    2 Covance Dallas Dallas Texas United States 75247

    Sponsors and Collaborators

    • Loxo Oncology, Inc.
    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Loxo Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT05176314
    Other Study ID Numbers:
    • 18366
    • J2N-MC-JZNW
    First Posted:
    Jan 4, 2022
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Apr 15, 2022