An Interaction Study of LY3200882 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3200882; Drug: Itraconazole

• Registration Number: NCT03792139
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-03
• Study Start: 2019-01-08
• Primary Completion: 2019-02-23
• Study Completion: 2019-02-23
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3200882	LY3200882	LY3200882 administered orally.
Itraconazole + LY3200882	LY3200882	Itraconazole + LY3200882 administered orally.
Itraconazole + LY3200882	Itraconazole	Itraconazole + LY3200882 administered orally.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882	Baseline through 72 hours post-dose	PK: Cmax of LY3200882
PK: Area Under the Concentration Curve (AUC) of LY3200882	Baseline through 72 hours post-dose	PK: AUC of LY3200882

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States