A Study of LY2835219 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

Effects of CYP3A Induction by Rifampin on the Pharmacokinetics of LY2835219 and Its Metabolites in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256267
• Other study ID #: 15174
• Secondary ID: I3Y-MC-JPBF
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods.

The study will last about 34 days. Screening is required within 28 days before study drug is given.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Overtly healthy sterile males or surgically sterile females or postmenopausal females

• Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)

Exclusion Criteria:

• Have participated in a clinical trial involving investigational product within the last 30 days

• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study

• Have an abnormal blood pressure

• Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C

• Have donated blood of more than 500 milliliters (mL) within the last month

• Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2835219
Administered orally
• Rifampin
Administered orally

Locations

Country	Name	City	State
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Dallas	Texas

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 Concentration (Cmax) of LY2835219		Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
Primary	PK: Area Under the Concentration Time Curve AUC(0-8) of LY2835219		Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours