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Clinical trial

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

ID
Name
LOXO-RAS-22002
Description
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.
Trial arms
Trial start
2023-05-08
Estimated PCD
2023-08-28
Trial end
2023-08-28
Status
Completed
Phase
Early phase I
Treatment
LY3537982
Administered orally.
Arms:
LY3537982 + Carbamazepine (Part 2), LY3537982 + Itraconazole (Part 1)
Itraconazole
Administered orally.
Arms:
LY3537982 + Itraconazole (Part 1)
Carbamazepine
Administered orally.
Arms:
LY3537982 + Carbamazepine (Part 2)
Size
30
Primary endpoint
Pharmacokinetics (PK): Maximum Observed Concentration (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
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
Predose on day 1 up to 72 hours postdose on day 9
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
Predose on day 1 up to 72 hours postdose on day 13
PK: AUClast of LY3537982 administered with or without carbamazepine
Predose on day 1 up to 72 hours postdose on day 13
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-01-24

1 organization

3 products

1 indication

Product
LY3537982
Indication
Healthy
Organization
Eli Lilly and Company
Product
Carbamazepine
Product
Itraconazole