Clinical trial NCT05630274: A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2022-11-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cardiodynamics: Model Predicted Baseline-corrected and Placebo-corrected QT Interval Corrected Using Fridericia's Correction (QTcF)(ΔΔQTcF)
timeFrame: Pre-dose up to 24 hour post-dose
measure: 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
timeFrame: Pre-dose up to 240 hour post-dose
measure: PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib
timeFrame: Pre-dose up to 240 hour post-dose
measure: PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib
timeFrame: Pre-dose up to 240 hour post-dose
measure: PK: Maximum observed concentration (Cmax) of Selpercatinib
timeFrame: Pre-dose up to 240 hour post-dose
measure: PK: Time to reach Cmax (Tmax) of Selpercatinib
timeFrame: Pre-dose up to 240 hour post-dose
measure: PK: Apparent first order terminal elimination rate constant (Kel) of Selpercatinib
timeFrame: Pre-dose up to 240 hour post-dose
measure: PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib
timeFrame: Pre-dose up to 240 hour post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: