Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY3041658 in Healthy Participants

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.
 
ClinicalTrials.gov Identifier: NCT04653168
Recruitment Status : Active, not recruiting
First Posted : December 4, 2020
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 3, 2020
First Posted Date  ICMJE December 4, 2020
Last Update Posted Date March 19, 2021
Actual Study Start Date  ICMJE December 7, 2020
Estimated Primary Completion Date May 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
  • 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
  • Visual Analog Scale (VAS) Score for Injection Site Pain [ Time Frame: Baseline up to Day 1 ]
    VAS Score for Injection Site Pain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658 [ Time Frame: Predose up to day 85 postdose ]
    PK: Cmax of LY3041658
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3041658 in Healthy Participants
Official Title  ICMJE A Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injections of LY3041658 in Healthy Participants
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: LY3041658
Administered SC
Study Arms  ICMJE
  • Experimental: LY3041658 Low Dose
    LY3041658 administered by subcutaneous (SC) injection.
    Intervention: Drug: LY3041658
  • Experimental: LY3041658 High Dose
    LY3041658 administered by SC injection.
    Intervention: Drug: LY3041658
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2020)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 24, 2021
Estimated Primary Completion Date May 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04653168
Other Study ID Numbers  ICMJE 17745
I7P-MC-DSAE ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date March 15, 2021

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