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

NCT05630274 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 17486J2G-OX-JZJGLOXO-RET-18032
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Cardiodynamics: Placebo-corrected Change From Baseline in QT Interval Corrected Using Fridericia's Correction (QTcF) (ΔΔQTcF) for Treatments A, B, and C

  The cardiodynamic assessment was performed through 12-lead electrocardiogram (ECG) extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Placebo-corrected change from baseline in QTcF (ΔΔQTcF) was calculated based on model-predicted effect

  Pre-dose, -0.25, -0.5, -0.25, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, and 24 hours post-dose

• 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 is reported.

  Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose

• PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib

  PK: AUC0-inf of Selpercatinib is reported.

  Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose

• PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib

  PK: AUC%extrap of Selpercatinib is reported.

  Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose

• PK: Maximum Observed Concentration (Cmax) of Selpercatinib

  PK: Cmax of Selpercatinib is reported.

  Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose

• PK: Time to Reach Cmax (Tmax) of Selpercatinib

  PK: Tmax of Selpercatinib is reported.

  Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose

• PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib

  PK: Kel of Selpercatinib is reported.

  Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose

• PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib

  PK: t½ of Selpercatinib is reported.

  Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose

Study Arms (4)

Treatment Sequence 1: ABCD

EXPERIMENTAL

Period 1: 320 milligram (mg) Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 2: 640 mg Selpercatinib (Treatment B) Period 3: 400 mg moxifloxacin (Treatment C) Period 4: Selpercatinib matching placebo (Treatment D) Participants received their assigned treatments in each of the above treatment period on Day 1 orally.

Drug: Selpercatinib

Treatment Sequence 2: BDAC

EXPERIMENTAL

Period 1: 640 mg Selpercatinib (Treatment B) Period 2: Selpercatinib matching placebo (Treatment D) Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 4: 400 mg moxifloxacin (Treatment C) Participants received their assigned treatments in each of the above treatment period on Day 1 orally.

Drug: Selpercatinib

Treatment Sequence 3: CADB

ACTIVE COMPARATOR

Period 1: 400 mg moxifloxacin (Treatment C) Period 2: Selpercatinib matching placebo (Treatment D) Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 4: 640 mg Selpercatinib (Treatment B) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. Period Title: Treatment Period 1

Drug: Moxifloxacin

Treatment Sequence 4: DCBA

PLACEBO COMPARATOR

Period 1: Selpercatinib matching placebo (Treatment D) Period 2: 400 mg moxifloxacin (Treatment C) Period 3: 640 mg Selpercatinib (Treatment B) Period 4: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Participants received their assigned treatments in each of the above treatment period on Day 1 orally.

Drug: Placebo

Interventions

Selpercatinib DRUG

Administered orally

Also known as: LY3527723, LOXO-292

Treatment Sequence 1: ABCD; Treatment Sequence 2: BDAC

Moxifloxacin DRUG

Administered orally

Treatment Sequence 3: CADB

Placebo DRUG

Administered orally.

Treatment Sequence 4: DCBA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, non-smoking, male or female (of non childbearing potential only or undergone sterilization procedures at least 6 months prior to the Screening) with no ECG abnormalities.
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Loxo Oncology, Inc.: collaborator

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

selpercatinib; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 29, 2022
• Study Start: April 16, 2019
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)