A Study of LY3185643 and rGlucagon in Healthy Participants

NCT ID: NCT02951780

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2017-03-01

Brief Summary

The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and what effects LY3185643 and rGlucagon have on the body. This study will also help to determine if LY3185643 is safe and well-tolerated.

This study will last at least 35 days, not including screening.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3185643

LY3185643 administered subcutaneous (SC)

Group Type: EXPERIMENTAL

LY3185643

Intervention Type: DRUG

Administered SC

rGlucagon

rGlucagon administered subcutaneous (SC)

Group Type: EXPERIMENTAL

rGlucagon

Intervention Type: DRUG

Administered SC

Interventions

LY3185643

Administered SC

Intervention Type: DRUG

rGlucagon

Administered SC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Are overtly healthy as determined by medical history and physical examination
• Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²)

Exclusion Criteria

• Have participated, within the last 30 days, in a clinical trial involving an investigational product
• Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the formulation
• History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the 12-lead ECG
• Abnormal blood pressure
• History of recurring symptomatic postural hypotension irrespective of the decrease in blood pressure, or asymptomatic postural hypotension at screening as defined as a decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of Mercury (mm Hg) within 3 minutes when changing from supine to standing position
• History of vasovagal response such as fainting
• History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
• History of/current insulinoma and/or pheochromocytoma
• Have used systemic glucocorticoids within 3 months before entry into the study

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Singapore, , Singapore

Countries

Singapore

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

I8Z-MC-APCA

Identifier Type: OTHER

Identifier Source: secondary_id

16502

Identifier Type: -

Identifier Source: org_study_id