A Drug-Drug Interaction Study of LY3537982 on Midazolam, Digoxin, and Rosuvastatin in Healthy Participants
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06111521
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the effects of multiple doses of LY3537982 on the pharmacokinetics (PK) of digoxin (a P-glycoprotein \[P-gp\] substrate), rosuvastatin (a breast cancer resistance protein \[BCRP)\] substrate), and midazolam (a substrate of Cytochrome P450 3A4 \[CYP3A4\]) in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982 with or without single doses of digoxin, rosuvastatin, and midazolam. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 23 and 11 days for part 1 and part 2, respectively, not including screening.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- Females who are lactating or of childbearing potential
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3537982 + Digoxin & Rosuvastatin (Part 1) LY3537982 Single oral doses of digoxin and rosuvastatin with or without multiple doses of LY3537982 administered orally LY3537982 + Digoxin & Rosuvastatin (Part 1) Digoxin Single oral doses of digoxin and rosuvastatin with or without multiple doses of LY3537982 administered orally LY3537982 + Digoxin & Rosuvastatin (Part 1) Rosuvastatin Single oral doses of digoxin and rosuvastatin with or without multiple doses of LY3537982 administered orally LY3537982 + Midazolam (Part 2) LY3537982 Single doses of midazolam administered either orally or intravenously (IV) with or without multiple doses of LY3537982 administered orally LY3537982 + Midazolam (Part 2) Midazolam Single doses of midazolam administered either orally or intravenously (IV) with or without multiple doses of LY3537982 administered orally
- Primary Outcome Measures
Name Time Method Part 1: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 Predose on day 11 up to day 17 Part 1: PK: Cmax of LY3537982
Part 2: PK: AUC[0-inf] of LY3537982 Predose on day 4 up to day 11 Part 2: PK: AUC\[0-inf\] of LY3537982
Part 1: PK: Cmax of Digoxin Predose on day 1 up to day 21 Part 1: PK: Cmax of Digoxin
Part 1: PK: AUClast of Rosuvastatin Predose on day 1 up to day 21 Part 1: PK: AUClast of Rosuvastatin
Part 2: PK: AUClast of LY3537982 Predose on day 4 up to day 11 Part 2: PK: AUClast of LY3537982
Part 2: PK: AUClast of Midazolam Predose on day 1 up to day 9 Part 2: PK: AUClast of Midazolam
Part 1: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 Predose on day 11 up to day 17 Part 1: PK: AUC\[0-inf\] of LY3537982
Part 1: PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 Predose on day 11 up to day 17 Part 1: PK: AUClast of LY3537982
Part 1: PK: AUClast of Digoxin Predose on day 1 up to day 21 Part 1: PK: AUClast of Digoxin
Part 1: PK: AUC[0-inf] of Rosuvastatin Predose on day 1 up to day 21 Part 1: PK: AUC\[0-inf\] of Rosuvastatin
Part 2: PK: Cmax of LY3537982 Predose on day 4 up to day 11 Part 2: PK: Cmax of LY3537982
Part 2: PK: Cmax of Midazolam Predose on day 1 up to day 9 Part 2: PK: Cmax of Midazolam
Part 2: PK: AUC[0-inf] of Midazolam Predose on day 1 up to day 9 Part 2: PK: AUC\[0-inf\] of Midazolam
Part 2: PK: Cmax of 1'-Hydroxymidazolam Predose on day 1 up to day 9 Part 2: PK: Cmax of 1'-Hydroxymidazolam
Part 1: PK: AUC[0-inf] of Digoxin Predose on day 1 up to day 21 Part 1: PK: AUC\[0-inf\] of Digoxin
Part 1: PK: Cmax of Rosuvastatin Predose on day 1 up to day 21 Part 1: PK: Cmax of Rosuvastatin
Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam Predose on day 1 up to day 9 Part 2: PK: AUC\[0-inf\] of 1'-Hydroxymidazolam
Part 2: PK: AUClast of 1'-Hydroxymidazolam Predose on day 1 up to day 9 Part 2: PK: AUClast of 1'-Hydroxymidazolam
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ICON Early Clinical & Bioanalytical Solutions
🇺🇸Salt Lake City, Utah, United States