A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT05468164
Collaborator
Loxo Oncology, Inc. (Industry)
19
1
4
3.4
5.5

Study Details

Study Description

Brief Summary

The main purpose of this study is to assess the effect of food on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it after a high-fat meal, and the effect of a change in gastric pH after multiple doses of omeprazole on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it when administered under fasted and fed conditions in healthy participants. The study will also evaluate the safety and tolerability of selpercatinib in healthy participants. The study will last up to 33 days excluding the screening period.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects
Actual Study Start Date :
May 31, 2018
Actual Primary Completion Date :
Sep 13, 2018
Actual Study Completion Date :
Sep 13, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Selpercatinib and omeprazole administered in ABCD treatment sequence

Period 1: Single oral dose of Selpercatinib administered in fasted state. Period 2: Single oral dose of Selpercatinib administered in fed state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4.

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

    Experimental: Selpercatinib and omeprazole administered in ABDC treatment sequence.

    Period 1: Single oral dose of Selpercatinib administered in fasted state. Period 2: Single oral dose of Selpercatinib administered in fed state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4.

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

    Experimental: Selpercatinib and omeprazole administered in BACD treatment sequence.

    Period 1: Single oral dose of Selpercatinib administered in fed state. Period 2: Single oral dose of Selpercatinib administered in fasted state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4.

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

    Experimental: Selpercatinib and omeprazole administered in BADC treatment sequence.

    Period 1: Single oral dose of Selpercatinib administered in fed state. Period 2: Single oral dose of Selpercatinib administered in fasted state. Period 3: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fed state. Period 4: Multiple daily oral doses of omeprazole administered along with single oral dose of selpercatinib in fasted state. Periods 1 and 2, 2 and 3 will be separated by a 7-day washout period. There will be no washout between Periods 3 and 4.

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

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib [Pre-dose up to 168 hour post-dose]

      PK: AUC0-t of Selpercatinib

    2. PK: Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib [Pre-dose up to 168 hour post-dose]

      PK: AUC0-inf of Selpercatinib

    3. PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib [Pre-dose up to 168 hour post-dose]

      PK: AUC%extrap of Selpercatinib

    4. PK: Maximum observed concentration (Cmax) of Selpercatinib [Pre-dose up to 168 hour post-dose]

      PK: Cmax of Selpercatinib

    5. PK: Time to reach Cmax (Tmax) of Selpercatinib [Pre-dose up to 168 hour post-dose]

      PK: Tmax of Selpercatinib

    6. PK: Apparent first order terminal elimination rate constant (Kel) of Selpercatinib [Pre-dose up to 168 hour post-dose]

      PK: Kel of Selpercatinib

    7. PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib [Pre-dose up to 168 hour post-dose]

      PK: CL/F of Selpercatinib

    8. PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib [Pre-dose up to 168 hour post-dose]

      PK: t½ of Selpercatinib

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Non-vasectomized, male participants must have agreed to use a condom with spermicide or abstain from sexual intercourse during the study until 6 months after the last dosing. (No restrictions were required for a vasectomized male provided his vasectomy had been performed 4 months or more prior to the first dosing of study drug)

    • If male, must have agreed not to donate sperm from the first dosing until 6 months after the last dosing

    • Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion

    • Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening

    • Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

    Exclusion Criteria:
    • Had a history of gastritis, gastrointestinal tract or hepatic disorder or other clinical condition that might have, in the opinion of the Principal Investigator or designee, and as confirmed by the Sponsor, affected the absorption, distribution, biotransformation, or excretion of LOXO 292 or omeprazole

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Celerion Tempe Arizona United States 85283

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Loxo Oncology, Inc.

    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:
    NCT05468164
    Other Study ID Numbers:
    • 17752
    • J2G-MC-JZJQ
    • LOXO-RET-18015
    First Posted:
    Jul 21, 2022
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 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:

    Study Results

    No Results Posted as of Jul 21, 2022