An Interaction Study of LY3200882 in Healthy Participants
Effects of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of LY3200882 in Healthy Subjects
2 other identifiers
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jan 2019
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedStudy Start
First participant enrolled
January 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2019
CompletedMarch 8, 2019
March 1, 2019
2 months
January 2, 2019
March 7, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
LY3200882
EXPERIMENTALLY3200882 administered orally.
Itraconazole + LY3200882
EXPERIMENTALItraconazole + LY3200882 administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males or postmenopausal females, as determined by medical history and physical examination
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Inc
Daytona Beach, Florida, 32117, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2019
First Posted
January 3, 2019
Study Start
January 8, 2019
Primary Completion
February 23, 2019
Study Completion
February 23, 2019
Last Updated
March 8, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share