A Study of LY2835219 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

Effect of Food on the Pharmacokinetics of LY2835219 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059148
• Other study ID #: 15175
• Secondary ID: I3Y-MC-JPBG
• Status: Completed
• Phase: Phase 1
• Start date: February 2014
• Est. completion date: August 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

Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy sterile males or surgically sterile or postmenopausal females

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

• Are able to eat a high-fat, high-calorie meal

Exclusion Criteria:

• Participated in a clinical trial involving investigational product within 30 days

• Abnormal blood pressure

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

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2835219
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: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms		Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Primary	Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms		Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Primary	Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms		Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Secondary	Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm		Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Secondary	Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm		Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Secondary	Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm		Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Secondary	Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)	Area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219.	Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period