Healthy
Conditions
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.
Interventions
DRUGLY3537982
Administered orally
DRUGDigoxin
Administered orally
DRUGRosuvastatin
Administered orally
DRUGMidazolam
Administered orally
Sponsors
Loxo Oncology, Inc.
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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: Cmax of Digoxin | Predose on day 1 up to day 21 | Part 1: PK: Cmax of Digoxin |
| 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: AUClast of Digoxin | Predose on day 1 up to day 21 | Part 1: PK: AUClast of Digoxin |
| Part 1: PK: Cmax of Rosuvastatin | Predose on day 1 up to day 21 | Part 1: PK: Cmax of Rosuvastatin |
| 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 1: PK: AUClast of Rosuvastatin | Predose on day 1 up to day 21 | Part 1: PK: AUClast 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: AUC[0-inf] of LY3537982 | Predose on day 4 up to day 11 | Part 2: PK: AUC\[0-inf\] of LY3537982 |
| Part 2: PK: AUClast of LY3537982 | Predose on day 4 up to day 11 | Part 2: PK: AUClast 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: AUClast of Midazolam | Predose on day 1 up to day 9 | Part 2: PK: AUClast 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 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 |
Countries
United States
Outcome results
None listed