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A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT05630274
Collaborator
Loxo Oncology, Inc. (Industry)
32
Enrollment
1
Location
4
Arms
2.2
Actual Duration (Months)
14.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to assess the effect of Selpercatinib (LY3527723) on the heart rate-corrected QT (QTc) interval. The study will last up to 41 days.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of LOXO-292 on the QTc Interval in Healthy Adult Subjects
Actual Study Start Date :
Apr 16, 2019
Actual Primary Completion Date :
Jun 21, 2019
Actual Study Completion Date :
Jun 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Selpercatinib (Dose level 1)

Selpercatinib administered as single dose orally.

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

    		•
    Experimental: Selpercatinib (Dose level 2)

    Selpercatinib administered as single dose orally.

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

    		•
    Active Comparator: Moxifloxacin

    Moxifloxacin administered as single dose orally.

    Drug: Moxifloxacin
    Administered orally
    Placebo Comparator: Placebo

    Placebo administered orally.

    Drug: Placebo
    Administered orally.

    Outcome Measures

    Primary Outcome Measures

    1. Cardiodynamics: Model Predicted Baseline-corrected and Placebo-corrected QT Interval Corrected Using Fridericia's Correction (QTcF)(ΔΔQTcF) [Pre-dose up to 24 hour post-dose]

      Cardiodynamics: Model Predicted Baseline-corrected and Placebo-corrected ΔΔQTcF

    2. Pharmacokinetics (PK): Area under the concentration-time curve from time 0 to the time of the last observed non-zero concentration (AUC0-t) of Selpercatinib [Pre-dose up to 240 hour post-dose]

      PK: AUC0-t of Selpercatinib

    3. PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib [Pre-dose up to 240 hour post-dose]

      PK: AUC0-inf of Selpercatinib

    4. PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib [Pre-dose up to 240 hour post-dose]

      PK: AUC%extrap of Selpercatinib

    5. PK: Maximum observed concentration (Cmax) of Selpercatinib [Pre-dose up to 240 hour post-dose]

      PK: Cmax of Selpercatinib

    6. PK: Time to reach Cmax (Tmax) of Selpercatinib [Pre-dose up to 240 hour post-dose]

      PK: Tmax of Selpercatinib

    7. PK: Apparent first order terminal elimination rate constant (Kel) of Selpercatinib [Pre-dose up to 240 hour post-dose]

      PK: Kel of Selpercatinib

    8. PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib [Pre-dose up to 240 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:

    • Healthy, adult, non-smoking, male or female (of non childbearing potential only or undergone sterilization procedures at least 6 months prior to the Screening)

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

    • Female of non childbearing potential: must have undergone sterilization procedures at least 6 months prior to the Screening

    • Males who are capable of fathering a child must agree to use contraception from the time of the dose administration through 6 months after the last dose

    Exclusion Criteria:

    • Estimated creatinine clearance <90 milliliter per minute (mL/min) at Screening or Check in (Day -1; rechecks will be permitted up to two times to confirm participant eligibility for study participation).

    • Has serum potassium levels <3.8 milliequivalents per liter (mEq/L) at Screening or Check in (Day -1; rechecks will be permitted up to two times to confirm participant eligibility for study participation).

    • Has serum calcium levels < 8.5 milligrams/deciliter (mg/dL) at Screening or Check in (Day -1; rechecks will be permitted up to two times to confirm participant eligibility for study participation).

    • Has serum magnesium levels <2.0 mEq/L at Screening or Check in (Day -1; rechecks will be permitted up to two times to confirm participant eligibility for study participation)

    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:
    NCT05630274
    Other Study ID Numbers:
    • 17486
    • J2G-OX-JZJG
    • LOXO-RET-18032
    First Posted:
    Nov 29, 2022
    Last Update Posted:
    Nov 29, 2022
    Last Verified:
    Nov 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:
    Moxifloxacin

    Study Results

    No Results Posted as of Nov 29, 2022