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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01477567
First received: November 18, 2011
Last updated: October 2, 2014
Last verified: October 2014

November 18, 2011
October 2, 2014
November 2011
March 2012   (final data collection date for primary outcome measure)
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs [ Time Frame: Baseline through Day 28 ] [ Designated as safety issue: Yes ]
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.
Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Baseline up to 28 days after administration of study drug ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01477567 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 [ Time Frame: Predose through Day 28 ] [ Designated as safety issue: No ]
    LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized.
  • Pharmacokinetics: Maximum Concentration (Cmax) [ Time Frame: Predose through Day 28 ] [ Designated as safety issue: No ]
    The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.
  • Change in Level of Blood Glucose Before and After a Standard Meal [ Time Frame: Baseline, Day 5, and Day 14 ] [ Designated as safety issue: No ]
    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.
  • Change in Level of C-peptide Before and After a Standard Meal [ Time Frame: Baseline, Day 5, and Day 14 ] [ Designated as safety issue: No ]
    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.
  • Change in Level of Glucagon Before and After a Standard Meal [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants Forming Antibody to LY3009385 [ Time Frame: Baseline through Day 28 ] [ Designated as safety issue: Yes ]
    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.
  • Pharmacokinetics: Area under the concentration curve (AUC) of LY3009385 [ Time Frame: Pre-dose up to 28 days post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum concentration (Cmax) [ Time Frame: Pre-dose up to 28 days post dose ] [ Designated as safety issue: No ]
  • Change in level of blood glucose before and after a standard meal [ Time Frame: Baseline, Day 5, and Day 14 after administration of study drug ] [ Designated as safety issue: Yes ]
  • Change in level of C-peptide before and after a standard meal [ Time Frame: Baseline, Day 5, and Day 14 after administration of study drug ] [ Designated as safety issue: No ]
  • Change in level of glucagon before and after a standard meal [ Time Frame: Baseline and Day 14 after administration of study drug ] [ Designated as safety issue: No ]
  • Number of participants forming antibody to LY3009385 [ Time Frame: Baseline and up to 28 days after administration of study drug ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A First-in-Human Study of LY3009385 in Healthy Participants
A Single Ascending Dose (SAD) Study of LY3009385 in Healthy Volunteers

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • Drug: LY3009385
  • Drug: Placebo
  • Experimental: 0.3 mg LY3009385
    LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
    Intervention: Drug: LY3009385
  • Experimental: 1 mg LY3009385
    LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
    Intervention: Drug: LY3009385
  • Experimental: 3 mg LY3009385
    LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
    Intervention: Drug: LY3009385
  • Experimental: 9 mg LY3009385
    LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
    Intervention: Drug: LY3009385
  • Experimental: 22 mg LY3009385
    LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
    Intervention: Drug: LY3009385
  • Experimental: 54 mg LY3009385
    LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
    Intervention: Drug: LY3009385
  • Placebo Comparator: Placebo
    Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01477567
14195, I5O-FW-GTCA
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP