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NCT06111521PHASE1COMPLETED

A Drug-Drug Interaction Study of LY3537982 on Midazolam, Digoxin, and Rosuvastatin in Healthy Participants

A PHASE 1 STUDY TO EVALUATE THE EFFECTS OF MULTIPLE DOSES OF LY3537982 ON THE SINGLE-DOSE PHARMACOKINETICS OF MIDAZOLAM, DIGOXIN, AND ROSUVASTATIN IN HEALTHY ADULT SUBJECTS

Sponsor: Eli Lilly and Company + Loxo Oncology, Inc.

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Healthy
Interventions
LY3537982, Digoxin, Rosuvastatin, Midazolam
Enrollment
35 participants
Primary completion
Apr 2024
Study completion
Apr 2024
First posted
Nov 2023
Last updated
Nov 2024

Primary Endpoints (CT.gov)

Part 1: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982

Time frame: Predose on day 11 up to day 17

Part 1: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982

Time frame: Predose on day 11 up to day 17

Part 1: PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982

Time frame: Predose on day 11 up to day 17

Part 1: PK: Cmax of Digoxin

Time frame: Predose on day 1 up to day 21

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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Source

Open on ClinicalTrials.gov