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NCT06111521 Clinical Trial

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

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06111521
Other study ID # LOXO-RAS-23007
Secondary ID J3M-OX-JZQJ
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date October 27, 2023
Est. completion date January 31, 2024

Study information
Verified date October 2023
Source Eli Lilly and Company
Contact Patient Advocacy
Phone 08555696305
Email clinicaltrials@loxooncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 56
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LY3537982
Administered orally
• Digoxin
Administered orally
• Rosuvastatin
Administered orally
• Midazolam
Administered orally
• Midazolam
Administered IV

Locations
Country Name City State
United States ICON Early Clinical & Bioanalytical Solutions Salt Lake City Utah

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Part 1: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 Part 1: PK: Cmax of LY3537982 Predose on day 11 up to day 17
Primary Part 1: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 Part 1: PK: AUC[0-inf] of LY3537982 Predose on day 11 up to day 17
Primary Part 1: PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 Part 1: PK: AUClast of LY3537982 Predose on day 11 up to day 17
Primary Part 1: PK: Cmax of Digoxin Part 1: PK: Cmax of Digoxin Predose on day 1 up to day 21
Primary Part 1: PK: AUC[0-inf] of Digoxin Part 1: PK: AUC[0-inf] of Digoxin Predose on day 1 up to day 21
Primary Part 1: PK: AUClast of Digoxin Part 1: PK: AUClast of Digoxin Predose on day 1 up to day 21
Primary Part 1: PK: Cmax of Rosuvastatin Part 1: PK: Cmax of Rosuvastatin Predose on day 1 up to day 21
Primary Part 1: PK: AUC[0-inf] of Rosuvastatin Part 1: PK: AUC[0-inf] of Rosuvastatin Predose on day 1 up to day 21
Primary Part 1: PK: AUClast of Rosuvastatin Part 1: PK: AUClast of Rosuvastatin Predose on day 1 up to day 21
Primary Part 2: PK: Cmax of LY3537982 Part 2: PK: Cmax of LY3537982 Predose on day 4 up to day 11
Primary Part 2: PK: AUC[0-inf] of LY3537982 Part 2: PK: AUC[0-inf] of LY3537982 Predose on day 4 up to day 11
Primary Part 2: PK: AUClast of LY3537982 Part 2: PK: AUClast of LY3537982 Predose on day 4 up to day 11
Primary Part 2: PK: Cmax of Midazolam Part 2: PK: Cmax of Midazolam Predose on day 1 up to day 9
Primary Part 2: PK: AUC[0-inf] of Midazolam Part 2: PK: AUC[0-inf] of Midazolam Predose on day 1 up to day 9
Primary Part 2: PK: AUClast of Midazolam Part 2: PK: AUClast of Midazolam Predose on day 1 up to day 9
Primary Part 2: PK: Cmax of 1'-Hydroxymidazolam Part 2: PK: Cmax of 1'-Hydroxymidazolam Predose on day 1 up to day 9
Primary Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam Predose on day 1 up to day 9
Primary Part 2: PK: AUClast of 1'-Hydroxymidazolam Part 2: PK: AUClast of 1'-Hydroxymidazolam Predose on day 1 up to day 9
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