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A Study of LY3041658 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT04653168
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety and tolerability of LY3041658 in healthy participants. The study will measure how the body absorbs, breaks down and gets rid of LY3041658.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3041658 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injections of LY3041658 in Healthy Participants
Actual Study Start Date : December 7, 2020
Estimated Primary Completion Date : May 24, 2021
Estimated Study Completion Date : May 24, 2021

Arm Intervention/treatment
Experimental: LY3041658 Low Dose
LY3041658 administered by subcutaneous (SC) injection.
Drug: LY3041658
Administered SC

Experimental: LY3041658 High Dose
LY3041658 administered by SC injection.
Drug: LY3041658
Administered SC




Primary Outcome Measures :
  1. Number of Participants With incidence and severity of Injection Site Reaction (ISR) [ Time Frame: Baseline up to Day 15 ]
    Number of Participants With incidence and severity of ISR

  2. Visual Analog Scale (VAS) Score for Injection Site Pain [ Time Frame: Baseline up to Day 1 ]
    VAS Score for Injection Site Pain


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658 [ Time Frame: Predose up to day 85 postdose ]
    PK: Cmax of LY3041658

  2. PK: Area Under the Concentration Versus Time Curve (AUC) from time 0 to infinity of LY3041658 [ Time Frame: Predose up to day 85 postdose ]
    PK: AUC(0-inf) of LY3041658



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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
Criteria

Inclusion Criteria:

  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and ECG.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Have Body mass index (BMI) within the range 18.5 - 35.0 kilograms per square meter (kg/m2) (inclusive).

Exclusion Criteria:

  • Have a significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immune, neurological, dermatological, or psychiatric disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the Study intervention or interfering with the interpretation of data.
  • Have self-perceived dullness or loss of sensation on either side of their abdomen.
  • Have any condition that could affect pain perception from an injection.
  • Have excessive tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection site assessments.

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 ClinicalTrials.gov identifier (NCT number): NCT04653168


Contacts
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Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@Lilly.com

Locations
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Singapore
Lilly Centre for Clinical Pharmacology Recruiting
Singapore, Singapore, 138623
Contact    64139811      
Principal Investigator: Ronan Kelly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
ClinicalTrials.gov Identifier: NCT04653168    
Other Study ID Numbers: 17745
I7P-MC-DSAE ( Other Identifier: Eli Lilly and Company )
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes