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Completed

NCT Number: NCT05860933

A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants

The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 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 Development Services, San Antonio, Texas, United States

Loading trial locations.

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

Itraconazole

Drug

Administered orally.

carbamazepine

Drug

Administered orally.

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole

    Time frame: Predose on day 1 up to 72 hours postdose on day 9

    PK: Cmax of LY3537982 administered with or without itraconazole

  2. PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole

    Time frame: Predose on day 1 up to 72 hours postdose on day 9

    PK: AUC[0-inf] of LY3537982 administered with or without itraconazole

  3. PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole

    Time frame: Predose on day 1 up to 72 hours postdose on day 9

    PK: AUClast of LY3537982 administered with or without itraconazole

  4. PK: Cmax of LY3537982 administered with or without carbamazepine

    Time frame: Predose on day 1 up to 72 hours postdose on day 13

    PK: Cmax of LY3537982 administered with or without carbamazepine

  5. PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine

    Time frame: Predose on day 1 up to 72 hours postdose on day 13

    PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine

  6. PK: AUClast of LY3537982 administered with or without carbamazepine

    Time frame: Predose on day 1 up to 72 hours postdose on day 13

    PK: AUClast of LY3537982 administered with or without carbamazepine

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 Itraconazole or Carbamazepine on the Single-Dose Pharmacokinetics of LY3537982 in Healthy Adult Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 16, 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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