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A Relative Bioavailability Study of Selpercatinib (LY3527723) in Healthy Participants

Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05136404
Collaborator
Eli Lilly and Company (Industry)
42
Enrollment
1
Location
3
Arms
3.3
Actual Duration (Months)
12.7
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 three different formulations in adult healthy participants. 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 59 days including the 28 days of screening period.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
42 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 Relative Bioavailability of Selpercatinib in 3 Formulations for Pediatric Use
Actual Study Start Date :
Dec 3, 2021
Actual Primary Completion Date :
Mar 14, 2022
Actual Study Completion Date :
Mar 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Selpercatinib (Formulation 1)

Selpercatinib (formulation 1) given orally on days 1, 8 or 15.

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

    		•
    Experimental: Selpercatinib (Formulation 2)

    Selpercatinib (formulation 2) given orally on days 1, 8 or 15.

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

    		•
    Experimental: Selpercatinib (Formulation 3)

    Selpercatinib (formulation 3) given orally on days 1, 8 or 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, 8 & 15 through Day 7, 14 & 21]

      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, 8 & 15 through Day 7, 14 & 21]

      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, 8 & 15 through Day 7, 14 & 21]

      PK: AUC[0-tlast] of Selpercatinib

    4. PK: Time to Maximum Observed Concentration (Tmax) of Selpercatinib [Predose on Day 1, 8 & 15 through Day 7, 14 & 21]

      PK: Tmax of Selpercatinib

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    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 18.0 to 35.0 kilograms per meter squared (kg/m²)

    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

    Site City State Country Postal Code
    1 LabCorp CRU, Inc. Daytona Beach Florida United States 32117

    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:
    NCT05136404
    Other Study ID Numbers:
    • 17821
    • J2G-MC-JZJU
    First Posted:
    Nov 29, 2021
    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

    Study Results

    No Results Posted as of Apr 15, 2022