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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05630274
• Other study ID #: 17486
• Secondary ID: J2G-OX-JZJGLOXO-
• Status: Completed
• Phase: Phase 1
• Start date: April 16, 2019
• Est. completion date: June 21, 2019

Study information

• Verified date: November 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Selpercatinib
Administered orally
• Moxifloxacin
Administered orally
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiodynamics: Model Predicted Baseline-corrected and Placebo-corrected QT Interval Corrected Using Fridericia's Correction (QTcF)(??QTcF)	Cardiodynamics: Model Predicted Baseline-corrected and Placebo-corrected ??QTcF	Pre-dose up to 24 hour post-dose
Primary	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	PK: AUC0-t of Selpercatinib	Pre-dose up to 240 hour post-dose
Primary	PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib	PK: AUC0-inf of Selpercatinib	Pre-dose up to 240 hour post-dose
Primary	PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib	PK: AUC%extrap of Selpercatinib	Pre-dose up to 240 hour post-dose
Primary	PK: Maximum observed concentration (Cmax) of Selpercatinib	PK: Cmax of Selpercatinib	Pre-dose up to 240 hour post-dose
Primary	PK: Time to reach Cmax (Tmax) of Selpercatinib	PK: Tmax of Selpercatinib	Pre-dose up to 240 hour post-dose
Primary	PK: Apparent first order terminal elimination rate constant (Kel) of Selpercatinib	PK: Kel of Selpercatinib	Pre-dose up to 240 hour post-dose
Primary	PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib	PK: t½ of Selpercatinib	Pre-dose up to 240 hour post-dose