Clinical trial NCT06111521: A Drug-Drug Interaction Study of LY3537982 on Midazolam, Digoxin, and Rosuvastatin in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2023-11-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Part 1: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982
timeFrame: Predose on day 11 up to day 17
measure: Part 1: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982
timeFrame: Predose on day 11 up to day 17
measure: Part 1: PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982
timeFrame: Predose on day 11 up to day 17
measure: Part 1: PK: Cmax of Digoxin
timeFrame: Predose on day 1 up to day 21
measure: Part 1: PK: AUC[0-inf] of Digoxin
timeFrame: Predose on day 1 up to day 21
measure: Part 1: PK: AUClast of Digoxin
timeFrame: Predose on day 1 up to day 21
measure: Part 1: PK: Cmax of Rosuvastatin
timeFrame: Predose on day 1 up to day 21
measure: Part 1: PK: AUC[0-inf] of Rosuvastatin
timeFrame: Predose on day 1 up to day 21
measure: Part 1: PK: AUClast of Rosuvastatin
timeFrame: Predose on day 1 up to day 21
measure: Part 2: PK: Cmax of LY3537982
timeFrame: Predose on day 4 up to day 11
measure: Part 2: PK: AUC[0-inf] of LY3537982
timeFrame: Predose on day 4 up to day 11
measure: Part 2: PK: AUClast of LY3537982
timeFrame: Predose on day 4 up to day 11
measure: Part 2: PK: Cmax of Midazolam
timeFrame: Predose on day 1 up to day 9
measure: Part 2: PK: AUC[0-inf] of Midazolam
timeFrame: Predose on day 1 up to day 9
measure: Part 2: PK: AUClast of Midazolam
timeFrame: Predose on day 1 up to day 9
measure: Part 2: PK: Cmax of 1'-Hydroxymidazolam
timeFrame: Predose on day 1 up to day 9
measure: Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam
timeFrame: Predose on day 1 up to day 9
measure: Part 2: PK: AUClast of 1'-Hydroxymidazolam
timeFrame: Predose on day 1 up to day 9
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON Early Clinical & Bioanalytical Solutions
state: Utah
Study officials:
affiliation: Loxo Oncology, Inc.
name: Yingying Guo-Avrutin
role: STUDY_DIRECTOR
References: