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Completed
NCT05630274
A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants
Conditions: Healthy
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 32
Sponsor: Eli Lilly and Company
Location: United States
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 ScreeningFemale of non childbearing potential: must have undergone sterilization procedures at least 6 months prior to the ScreeningMales 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 doseExclusion 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)
Source: ClinicalTrials.gov (NCT05630274). StuddyBuddy aggregates publicly available trial information.