Clinical trial NCT03025009: A Study of LY3192767 in Healthy Participants
Official title: A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-01-19
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Have a body mass index (BMI) of \>18.5 and \<30.0 kilogram per square meter (kg/m²), inclusive

Exclusion Criteria:

* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
* Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug
* Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Study Completion (up to about Day 49)
Secondary outcomes:
measure: Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3192767
timeFrame: Predose through 336 Hours
measure: PK: Maximum Serum Concentration (Cmax) of LY3192767
timeFrame: Predose through 336 Hours
measure: PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767
timeFrame: Predose through 336 Hours
measure: Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767
timeFrame: Predose through 36 Hours During Clamp Procedure
measure: PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767
timeFrame: Predose through 36 Hours During Clamp Procedure
measure: PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767
timeFrame: Predose through 36 Hours During Clamp Procedure
measure: PD: Change from Baseline in Free Fatty Acids
timeFrame: Predose through 48 Hours Postdose
measure: PD: Change from Baseline in Glycerol
timeFrame: Predose through 48 Hours Postdose
measure: PD: Change from Baseline in Triglycerides
timeFrame: Predose through 48 Hours Postdose
Other outcomes:
Locations:
city: Neuss
country: Germany
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.
state: Nordrhein-Westfalen
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: