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

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: April 13, 2012
Last verified: April 2012
History of Changes
  Purpose

The main purpose of this study is to determine the safety of LY3009385 in healthy people. 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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: LY3009385
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Single Ascending Dose (SAD) Study of LY3009385 in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 42
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.3 mg LY3009385
Single 0.3 mg dose of LY3009385 given as a subcutaneous (SC) injection
 Drug: LY3009385
Given as a SC injection
Experimental: 1 mg LY3009385
Single 1 mg dose of LY3009385 given as a SC injection
 Drug: LY3009385
Given as a SC injection
Experimental: 3 mg LY3009385
Single 3 mg dose of LY3009385 given as a SC injection
 Drug: LY3009385
Given as a SC injection
Experimental: 9 mg LY3009385
Single 9 mg dose of LY3009385 given as a SC injection
 Drug: LY3009385
Given as a SC injection
Experimental: 27 mg LY3009385
Single 27 mg dose of LY3009385 given as a SC injection
 Drug: LY3009385
Given as a SC injection
Experimental: 54 mg LY3009385
Single 54 mg dose of LY3009385 given as a SC injection
 Drug: LY3009385
Given as a SC injection
Placebo Comparator: Placebo
Saline given as a SC injection
 Drug: Placebo
Given as a SC injection

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477567

Locations
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, Singapore
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01477567     History of Changes
Other Study ID Numbers: 14195, I5O-FW-GTCA
Study First Received: November 18, 2011
Last Updated: April 13, 2012
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 13, 2013