A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants

Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05089019
Collaborator
Eli Lilly and Company (Industry)
310
Enrollment
4
Locations
2
Arms
7.7
Anticipated Duration (Months)
77.5
Patients Per Site
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it, when given as different formulations. The information about any adverse effects experienced will be collected and the tolerability of selpercatinib will also be evaluated. The study may last up to 56 days including the 28 days of screening period.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
310 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-Label, Randomized Study to Evaluate the Bioequivalence of Selpercatinib Formulations
Actual Study Start Date :
Oct 29, 2021
Anticipated Primary Completion Date :
Jan 8, 2022
Anticipated Study Completion Date :
Jun 19, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Selpercatinib (Test)

Selpercatinib given orally on days 1 and 15.

Drug: Selpercatinib
Administered orally
Other Names:
  • LY3527723
  • LOXO-292
  • Active Comparator: Selpercatinib (Reference)

    Selpercatinib given orally on days 1 and 15.

    Drug: Selpercatinib
    Administered orally
    Other Names:
  • LY3527723
  • LOXO-292
  • Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib [Predose on Day 1 & 15 through Day 14 & 28]

      PK: Cmax of Selpercatinib

    2. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib [Predose on Day 1 & 15 through Day 14 & 28]

      PK: AUC[0-∞] of Selpercatinib

    3. PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib [Predose on Day 1 & 15 through Day 14 & 28]

      PK: AUC[0-tlast] of Selpercatinib

    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 including medical history, physical examination, and vital signs.

    • Participants who have clinical laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.

    Exclusion Criteria:
    • Have a history of allergic reactions to medications or food products

    • Have a clinically significant abnormality of blood pressure and/or pulse rate as determined by the investigator

    • Clinically significant abnormalities on ECG as determined by the investigator or prolongation of the QTcB or QTcF >450 msec at screening

    • Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of selpercatinib

    • Have a 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; or of interfering with the interpretation of data. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable

    • Use of H2 blockers, proton pump inhibitors, and other drugs that affect selpercatinib exposure within 7 days of screening

    • Are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen (≤2 g/24 hours), hormonal contraception, or hormone replacement therapy)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Anaheim Clinical Trials, LLCAnaheimCaliforniaUnited States92801
    2LabCorp CRU, Inc.Daytona BeachFloridaUnited States32117
    3Covance DallasDallasTexasUnited States75247
    4LabCorp CRU, Inc.MadisonWisconsinUnited States53704

    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:
    NCT05089019
    Other Study ID Numbers:
    • 18177
    • J2G-MC-JZJZ
    First Posted:
    Oct 22, 2021
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 15, 2021
    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

    Study Results

    No Results Posted as of Nov 18, 2021