Clincosm LogoSign in Get a demo

A Study of [14C]-LOXO-783 in Healthy Adult Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06102512
Collaborator
Loxo Oncology, Inc. (Industry)
16
Enrollment
1
Location
2
Arms
2.6
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 ([¹⁴C]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and [¹⁴C]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Open-label Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LOXO-783 in Healthy Adult Subjects
Anticipated Study Start Date :
Oct 23, 2023
Anticipated Primary Completion Date :
Jan 11, 2024
Anticipated Study Completion Date :
Jan 11, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: [¹⁴C]-LOXO-783 (Part 1)

Single dose of [¹⁴C]-LOXO-783 administered orally

Drug: [¹⁴C]-LOXO-783
Administered orally
Other Names:
  • LY3849524

    		•
    Experimental: LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)

    Single dose of LOXO-783 administered orally followed by single dose of [¹⁴C]-LOXO-783 administered intravenously (IV)

    Drug: LOXO-783
    Administered orally
    Other Names:
  • LY3849524

    • Drug: [¹⁴C]-LOXO-783
    Administered IV
    Other Names:
  • LY3849524

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur) [Predose on day 1 up to postdose on day 21 (Part 1)]

      PK: Feur

    2. PK: Cumulative Feur [Predose on day 1 up to postdose on day 21 (Part 1)]

      PK: Cumulative Feur

    3. PK: Fraction of Dose Excreted in Feces (Fefeces) [Predose on day 1 up to postdose on day 21 (Part 1)]

      PK: Fefeces

    4. PK: Cumulative Fefeces [Predose on day 1 up to postdose on day 21 (Part 1)]

      PK: Cumulative Fefeces

    5. PK: Fraction of Dose Excreted in Expired Air (Feair) [Predose on day 1 up to postdose on day 21 (Part 1)]

      PK: Feair

    6. PK: Absolute Bioavailability (F) of LOXO-783 [Predose on day 1 up to postdose on day 9 (Part 2)]

      PK: F of LOXO-783

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator

    • Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)

    • Female participants of non-childbearing potential and male participants who follow standard contraceptive methods

    Exclusion Criteria:

    • History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor

    • Known ongoing alcohol and/or drug abuse within 2 years prior to Screening

    • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fortrea Clinical Research Madison Wisconsin United States 53704

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Loxo Oncology, Inc.

    Investigators

    • Study Director: Yingying Guo-Avrutin, Loxo Oncology, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT06102512
    Other Study ID Numbers:
    • LOXO-PIK-23005
    • J4C-OX-JZUE
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 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

    Study Results

    No Results Posted as of Oct 26, 2023