An Interaction Study of LY3200882 in Healthy Participants

Effects of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of LY3200882 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3200882; Drug: Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3200882; LY3200882 administered orally.	Drug: LY3200882; Administered orally.
Experimental: Itraconazole + LY3200882; Itraconazole + LY3200882 administered orally.	Drug: LY3200882; Administered orally.; Drug: Itraconazole; Administered orally.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): February 23, 2019
• Study Completion (Actual): February 23, 2019

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: 16616; I8X-MC-JECC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No