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Completed

NCT Number: NCT06111521

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Clinical & Bioanalytical Solutions

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3537982

Drug

Administered orally

Other names: Olomorasib

Digoxin

Drug

Administered orally

Rosuvastatin

Drug

Administered orally

midazolam

Drug

Administered orally

Primary outcomes

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

    Time frame: Predose on day 11 up to day 17

    Part 1: PK: Cmax of LY3537982

  2. 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[0-inf] of LY3537982

  3. 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: AUClast of LY3537982

  4. Part 1: PK: Cmax of Digoxin

    Time frame: Predose on day 1 up to day 21

    Part 1: PK: Cmax of Digoxin

  5. Part 1: PK: AUC[0-inf] of Digoxin

    Time frame: Predose on day 1 up to day 21

    Part 1: PK: AUC[0-inf] of Digoxin

  6. Part 1: PK: AUClast of Digoxin

    Time frame: Predose on day 1 up to day 21

    Part 1: PK: AUClast of Digoxin

  7. Part 1: PK: Cmax of Rosuvastatin

    Time frame: Predose on day 1 up to day 21

    Part 1: PK: Cmax of Rosuvastatin

  8. Part 1: PK: AUC[0-inf] of Rosuvastatin

    Time frame: Predose on day 1 up to day 21

    Part 1: PK: AUC[0-inf] of Rosuvastatin

  9. Part 1: PK: AUClast of Rosuvastatin

    Time frame: Predose on day 1 up to day 21

    Part 1: PK: AUClast of Rosuvastatin

  10. Part 2: PK: Cmax of LY3537982

    Time frame: Predose on day 4 up to day 11

    Part 2: PK: Cmax of LY3537982

  11. Part 2: PK: AUC[0-inf] of LY3537982

    Time frame: Predose on day 4 up to day 11

    Part 2: PK: AUC[0-inf] of LY3537982

  12. Part 2: PK: AUClast of LY3537982

    Time frame: Predose on day 4 up to day 11

    Part 2: PK: AUClast of LY3537982

  13. Part 2: PK: Cmax of Midazolam

    Time frame: Predose on day 1 up to day 9

    Part 2: PK: Cmax of Midazolam

  14. Part 2: PK: AUC[0-inf] of Midazolam

    Time frame: Predose on day 1 up to day 9

    Part 2: PK: AUC[0-inf] of Midazolam

  15. Part 2: PK: AUClast of Midazolam

    Time frame: Predose on day 1 up to day 9

    Part 2: PK: AUClast of Midazolam

  16. Part 2: PK: Cmax of 1'-Hydroxymidazolam

    Time frame: Predose on day 1 up to day 9

    Part 2: PK: Cmax of 1'-Hydroxymidazolam

  17. Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam

    Time frame: Predose on day 1 up to day 9

    Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam

  18. Part 2: PK: AUClast of 1'-Hydroxymidazolam

    Time frame: Predose on day 1 up to day 9

    Part 2: PK: AUClast of 1'-Hydroxymidazolam

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Loxo Oncology, Inc.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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