Phase 1
N=32
A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05630274 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Cardiodynamics: Placebo-corrected Change From Baseline in QT Interval Corrected Using Fridericia's Correction (QTcF) (ΔΔQTcF) for Treatments A, B, and C — 3.4; 4.4; 6.4 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Selpercatinib (Drug); Moxifloxacin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiodynamics: Placebo-corrected Change From Baseline in QT Interval Corrected Using Fridericia's Correction (QTcF) (ΔΔQTcF) for Treatments A, B, and C |
3.4; 4.4; 6.4 | — |
| 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 |
33730; 42670 | — |
| PRIMARY PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib |
33830; 42830 | — |
| PRIMARY PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib |
0.2986; 0.3734 | — |
| PRIMARY PK: Maximum Observed Concentration (Cmax) of Selpercatinib |
2024; 2356 | — |
| PRIMARY PK: Time to Reach Cmax (Tmax) of Selpercatinib |
1.557; 2.051 | — |
| PRIMARY PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib |
0.02515; 0.02459 | — |
| PRIMARY PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib |
31.189; 30.582 | — |
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) 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
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)
Data sourced from ClinicalTrials.gov (NCT05630274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.