A First-in-Human Study of LY3009385 in Healthy Participants

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Single Ascending Dose (SAD) Study of LY3009385 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477567
• Other study ID #: 14195
• Secondary ID: I5O-FW-GTCA
• Status: Completed
• Phase: Phase 1
• First received: November 18, 2011
• Last updated: October 2, 2014
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: October 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.

Description:

This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo.

Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data.

The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Are a healthy male or a female who cannot become pregnant

• Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2) at screening

• Have blood pressure, pulse rate, as well as blood and urine laboratory test results acceptable for the study

• Have veins suitable for easy blood collection

• Are reliable and willing to be available for the whole study and be willing to follow study procedures

• Have given consent to participate in this study

Exclusion Criteria:

• Are currently participating in or were in another new drug or device or in any medical research study in the last 30 days

• Currently have or used to have allergies or other health problems or laboratory test results that in the opinion of the doctor, could make it unsafe for the participant to participate, or interfere with understanding the results of this study

• Have received live vaccine(s) within 1 month of screening, or intend to during the study

• Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing

• Have a weakened immune system

• Have previously completed or withdrawn from this study

• Have illnesses or conditions that may increase risk when taking the study medication or interfere with the interpretation of data in this study

• Have electrocardiogram (ECG) readings that are not suitable for the study

• Are using or intend to use over-the-counter medications or prescription medications within 7 and 14 days (respectively) from the start of the first study dosing until end of the study

• Have a history of drug or alcohol abuse

• Are infected with hepatitis B

• Are infected with human immunodeficiency virus (HIV)

• Have donated 450 milliliters (mL) or more of blood in the last 3 months or made any blood donation within the last month

• Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are unwilling to abstain from alcohol 24 hours before dosing until the completion of each inpatient study period

• Smoke more than 10 cigarettes per day or are unable or unwilling to refrain from smoking while at the clinic

• Are unwilling or unable to follow dietary requirements/restrictions for the study and only consume only the meals provided during inpatient stays at the clinical research unit

• Are deemed unsuitable to participate by the study doctor for any other reasons

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3009385

• Placebo

Locations

Country	Name	City	State
Singapore	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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs	The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	Baseline through Day 28	Yes
Secondary	Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385	LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized.	Predose through Day 28	No
Secondary	Pharmacokinetics: Maximum Concentration (Cmax)	The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.	Predose through Day 28	No
Secondary	Change in Level of Blood Glucose Before and After a Standard Meal	The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.	Baseline, Day 5, and Day 14	No
Secondary	Change in Level of C-peptide Before and After a Standard Meal	The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.	Baseline, Day 5, and Day 14	No
Secondary	Change in Level of Glucagon Before and After a Standard Meal	The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.	Baseline, Day 14	No
Secondary	Number of Participants Forming Antibody to LY3009385	The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.	Baseline through Day 28	Yes