A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants
A Phase 1 Study to Evaluate the Effects of Multiple Doses of Itraconazole or Carbamazepine on the Single-Dose Pharmacokinetics of LY3537982 in Healthy Adult Subjects
Sponsor: Eli Lilly and Company + Loxo Oncology, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole
Time frame: Predose on day 1 up to 72 hours postdose on day 9
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole
Time frame: Predose on day 1 up to 72 hours postdose on day 9
PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole
Time frame: Predose on day 1 up to 72 hours postdose on day 9
PK: Cmax of LY3537982 administered with or without carbamazepine
Time frame: Predose on day 1 up to 72 hours postdose on day 13
Eligibility Criteria
Inclusion Criteria: * Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease * Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive Exclusion Criteria: * Females who are lactating or of childbearing potential * Clinically significant history of any drug sensitivity, drug allergy, or food allergy
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Expert commentary on why this trial matters and what to watch for.
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