An Interaction Study of LY3200882 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Itraconazole; Drug: LY3200882

Study type: Interventional

Funder types: Industry

Identifiers

NCT03792139

16616

I8X-MC-JECC (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the effect of itraconazole on the amount of LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will occur up to 28 days prior to enrollment.

Enrollment: 23 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males or postmenopausal females, as determined by medical history and physical examination

Exclusion criteria

• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing and during the study (with the exception of vitamins and occasional acetaminophen or ibuprofen, which will be permitted at the discretion of the investigator). Drugs that are known substrates, inducers, or inhibitors of CYP3A4 are specifically excluded within 30 days of dosing and throughout the study

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

LY3200882

Experimental group

Description:

LY3200882 administered orally.

Treatment:

Drug: LY3200882

Itraconazole + LY3200882

Experimental group

Description:

Itraconazole + LY3200882 administered orally.

Treatment:

Drug: LY3200882

Drug: Itraconazole