Clinical trial NCT02951780: A Study of LY3185643 and rGlucagon in Healthy Participants
Official title: A Randomized, 9-Way, Single-Dose, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of LY3185643 and rGlucagon in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon
timeFrame: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon
timeFrame: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
measure: Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon
timeFrame: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
measure: Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon
timeFrame: -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose
measure: Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon
timeFrame: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
measure: Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon
timeFrame: -5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: