A Study of LY3143753 and LY3185643 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3143753 and LY3185643 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342314
• Other study ID #: 15503
• Secondary ID: I7U-MC-GAHA
• Status: Completed
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: September 2016

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 study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Overtly healthy males or females

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

Exclusion Criteria:

• Are investigator site personnel directly affiliated with this study and their immediate families

• Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device

• Have participated, within the last 3 months, in a clinical trial

• Have known or ongoing psychiatric disorders

• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies

• Show evidence of hepatitis C and/or positive hepatitis C antibody

• Show evidence of hepatitis B and/or positive hepatitis B surface antigen

• History of/current phaeochromocytoma

• History of/current insulinoma

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3143753 (Part A)
Administered via SC injection
• LY3185643 (Part B)
Administered via SC injection
• Placebo (Part A and Part B)
Administered via SC injection
• rGlucagon (Part B)
Administered via SC injection

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	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.	Baseline to Study Completion (Up to 84 Days)
Secondary	Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Secondary	PK: Cmax of Part B		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Secondary	PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-8]) of Part A		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Secondary	PK: AUC(0-8) of Part B		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Secondary	PK: Time to Maximum Drug Concentration (Tmax) of Part A		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Secondary	PK: Tmax of Part B		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Secondary	Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
Secondary	PD Absolute Maximum Blood Glucose of Part B		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
Secondary	PD: Maximum Glucose Increase (Gmax) of Part A		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
Secondary	PD: Gmax of Part B		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
Secondary	PD: Time to Maximum Blood Glucose (Gtmax) of Part A		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
Secondary	PD: Gtmax of Part B		Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
Secondary	QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A		Baseline, 8 hours after drug administration
Secondary	QTcF Change From Baseline of Part B		Baseline, 8 hours after drug administration