A Study of LY2835219 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: LY2835219; Drug: ¹³C₈-LY2835219

• Registration Number: NCT02327143
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-30
• Study Start: 2015-01
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2017-10
• Results First Submitted: 2017-10-27
• Results First Submitted QC: 2017-10-27
• Last Update Submitted: 2017-10-27
• Results First Posted: 2018-08-06
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
200 mg LY2835219	LY2835219	200 mg LY2835219 administered orally on day 1.
0.4 mg ¹³C₈-LY2835219	¹³C₈-LY2835219	0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] 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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

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, United Kingdom