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A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05906836
Collaborator
(none)
28
Enrollment
1
Location
1
Arm
3.8
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to determine the effect of selpercatinib 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 selpercatinib 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
Anticipated Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single Dose Selpercatinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Anticipated Study Start Date :
Jun 16, 2023
Anticipated Primary Completion Date :
Oct 10, 2023
Anticipated Study Completion Date :
Oct 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rosuvastatin + Selpercatinib

Rosuvastatin administered orally on day 1 followed by rosuvastatin administered with selpercatinib on day 5 orally.

Drug: Rosuvastatin
Administered orally.

Drug: Selpercatinib
Administered orally.
Other Names:
  • LY3527723
  • LOXO-292
  • Retevmo®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin [Pre-dose up to 72 hours post-dose]

      PK: Cmax of Rosuvastatin

    2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin [Pre-dose up to 72 hours post-dose]

      PK: AUC(0-∞) of Rosuvastatin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Participants who are overtly healthy as determined by medical evaluation

    • Participant must be Caucasian

    • Body mass index (BMI) within the range of 19.0 to 32.0 kilograms per meter squared (kg/m²)

    Exclusion Criteria:

    • Have known allergies to selpercatinib-related compounds or any components of the formulation of selpercatinib, or or rosuvastatin

    • • Have a significant previous or current history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product

    • Have used or are intending to use over-the-counter or prescription medication, including dietary supplements and herbal medications, within 14 days prior to dosing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Labcorp Clinical Research LP Dallas Texas United States 75247

    Sponsors and Collaborators

    • 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:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05906836
    Other Study ID Numbers:
    • 18727
    • J2G-MC-JZPB
    First Posted:
    Jun 18, 2023
    Last Update Posted:
    Jun 18, 2023
    Last Verified:
    Jun 1, 2023
    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
    Keywords provided by Eli Lilly and Company
    Drug Drug Interaction Trial
    Selpercatinib (Retevmo®)
    Additional relevant MeSH terms:
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Jun 18, 2023