A Study of LY2835219 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

An Absolute Bioavailability Study of LY2835219 in Healthy Subjects Using the Intravenous Tracer Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327143
• Other study ID #: 15533
• Secondary ID: I3Y-MC-JPBS
• Status: Completed
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: February 2015

Study information

• Verified date: October 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this 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 as an intravenous infusion (given directly into a vein via a small needle).

The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function.

The study will last about 10 days. Screening is required within 28 days before study drug is given.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

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)

• Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

• Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

• Have participated in a clinical trial involving investigational product within the last 90 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 consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A inducer, herbal supplements, grapefruits or grapefruit containing products, Seville oranges or Seville orange containing products, star fruits or star fruit containing products within 2 weeks prior to dosing or intend to consume during the study

• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2835219
Administered orally
• ¹³C8-LY2835219
Administered IV

Locations

Country	Name	City	State
United Kingdom	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.	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-8)] of LY2835219 and ¹³C8-LY2835219		Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
Secondary	PK: Maximum Observed Concentration (Cmax) of LY2835219		Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
Secondary	PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219		Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose