Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants

Stopped early · Phase 1

Conditions studied: Healthy

In brief

The main purpose of this study is to learn about how itraconazole and carbamazepine affect the levels of LY3410738 in the blood stream of healthy participants. Participation could last up to 75 days.

Key facts

Study ID

NCT05205447

Run by

Eli Lilly and Company

People needed

27

Starts

2022-01-05

Expected to finish

2022-04-12

Last updated by the study team

2022-12-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Females of non-childbearing potential and males capable of fathering a child must use contraception
• Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
• Participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
• Able to comply with all study procedures, including the 15-night stay for those participating in part 1 or 25-night stay for those participating in part 2 at the Clinical Research Unit and follow-up phone call.

You may not qualify if…

• History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
• Allergic disease
• Dermatological disease
• Renal disease
• Liver disease
• Pancreatitis
• Gastrointestinal disease
• Biliary disease
• Metabolic disease
• Hematological disease
• Pulmonary disease
• Neurological disease
• Cancer within the past 5 years
• Cardiovascular disease
• Participants with out-of-range, at-rest vital signs.
• Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
• Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
• Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
• Use or intention to use any prescription or over-the-counter medications within 14 days or 5 half-lives (if known) prior to the first dose administration (Day 1) and through end of trial.
• History or presence of any illness or psychiatric condition, that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
• Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
• Receipt of blood products within 2 months prior to Check-in (Day -1).
• Significant history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• For Part 1 only, Having impaired hearing or a history of hearing problems
• For Part 2 only, History of serious dermatological adverse reaction, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, or DRESS

Where it is running

• LabCorp CRU, Inc. — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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