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A Study of LY3025876 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01528124
Recruitment Status : Completed
First Posted : February 7, 2012
Results First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: LY3025876 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3025876 in Healthy Subjects
Study Start Date : February 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Placebo Comparator: Placebo
0.9% sodium chloride given as a single subcutaneous injection
Drug: Placebo
Given as a subcutaneous injection

Experimental: LY3025876
Single escalating doses of LY3025876 given as subcutaneous injections
Drug: LY3025876
Given as a subcutaneous injection

Primary Outcome Measures :
  1. Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events [ Time Frame: Baseline up to 28 days post-dose ]
    Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.

Secondary Outcome Measures :
  1. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose ]
    Area under the concentration-versus-time curve from time zero to infinity [AUC(0-∞)] of LY3025876.

  2. Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose ]
  3. Number of Participants Developing Anti-LY3025876 Antibodies [ Time Frame: Day 28 post-dose ]
    Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Must be either a healthy male or a healthy female who cannot become pregnant
  • Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m^2), inclusive, at screening

Exclusion Criteria:

  • Are allergic to LY3025876 or related compounds
  • Have a history of significant disease that may affect the actions of drugs or may pose a risk when taking the study medication
  • Have a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids. Corticosteroids are mainly used to control inflammation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01528124

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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, 117597
Sponsors and Collaborators
Eli Lilly and Company
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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

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Responsible Party: Eli Lilly and Company Identifier: NCT01528124     History of Changes
Other Study ID Numbers: 14346
I6D-FW-SMRA ( Other Identifier: Eli Lilly and Company )
First Posted: February 7, 2012    Key Record Dates
Results First Posted: July 16, 2018
Last Update Posted: July 16, 2018
Last Verified: September 2017