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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3537982
* Drug: Itraconazole
* Drug: Carbamazepine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3537982 + Itraconazole (Part 1)<br>LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally. | Drug: LY3537982<br>* Administered orally.<br>Drug: Itraconazole<br>* Administered orally.<br>|
| Experimental: LY3537982 + Carbamazepine (Part 2)<br>LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally. | Drug: LY3537982<br>* Administered orally.<br>Drug: Carbamazepine<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole | PK: Cmax of LY3537982 administered with or without itraconazole | Predose on day 1 up to 72 hours postdose on day 9 | 
| PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole | PK: AUC[0-inf] of LY3537982 administered with or without itraconazole | Predose on day 1 up to 72 hours postdose on day 9 | 
| PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole | PK: AUClast of LY3537982 administered with or without itraconazole | Predose on day 1 up to 72 hours postdose on day 9 | 
| PK: Cmax of LY3537982 administered with or without carbamazepine | PK: Cmax of LY3537982 administered with or without carbamazepine | Predose on day 1 up to 72 hours postdose on day 13 | 
| PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine | PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine | Predose on day 1 up to 72 hours postdose on day 13 | 
| PK: AUClast of LY3537982 administered with or without carbamazepine | PK: AUClast of LY3537982 administered with or without carbamazepine | Predose on day 1 up to 72 hours postdose on day 13 |