An Interaction Study of LY3200882 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792139
• Other study ID #: 16616
• Secondary ID: I8X-MC-JECC
• Status: Completed
• Phase: Phase 1
• Start date: January 8, 2019
• Est. completion date: February 23, 2019

Study information

• Verified date: March 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 23, 2019
• Est. primary completion date: February 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3200882
Administered orally.
• Itraconazole
Administered orally.

Locations

Country	Name	City	State
United States	Covance Clinical Research Inc	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882	PK: Cmax of LY3200882	Baseline through 72 hours post-dose
Primary	PK: Area Under the Concentration Curve (AUC) of LY3200882	PK: AUC of LY3200882	Baseline through 72 hours post-dose