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

• Status: Completed
• Trial end date: 2019-06-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Loxo Oncology, Inc.
• Treatments: Moxifloxacin

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)