Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Ramucirumab (LY3009806) 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: NCT04495478
Recruitment Status : Active, not recruiting
First Posted : July 31, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 30, 2020
First Posted Date  ICMJE July 31, 2020
Last Update Posted Date February 21, 2021
Actual Study Start Date  ICMJE July 30, 2020
Estimated Primary Completion Date May 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Day 90 ]
    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
  • Percentage of Participants with an Injection Site Reaction (ISR[s]) [ Time Frame: Day 1 Predose through Day 90 ]
    Percentage of Participants with an ISR(s)
  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Ramucirumab [ Time Frame: Baseline through Day 90 ]
    PK: AUC of Ramucirumab
  • PK: Maximum Concentration (Cmax) of Ramucirumab [ Time Frame: Baseline through Day 90 ]
    PK: Cmax of Ramucirumab
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ramucirumab (LY3009806) in Healthy Participants
Official Title  ICMJE A Single-Dose Study in Healthy Participants to Characterize Ramucirumab Pharmacokinetics and Investigate Injection Site Reactions Following an Intravenous Infusion or Subcutaneous Administration of Ramucirumab
Brief Summary

This study evaluates a new formulation of ramucirumab, a drug approved for several types of cancer.

In this study of healthy participants, a small amount of ramucirumab will be given by injection either into a vein or just under the skin. Study doctors will measure the amount of ramucirumab in the bloodstream.

Side effects and tolerability will be documented. The study will last for about 16 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Ramucirumab - IV
    Administered IV.
    Other Name: LY3009806
  • Drug: Placebo - IV
    Administered IV.
  • Drug: Ramucirumab - SC
    Administered SC.
    Other Name: LY3009806
  • Drug: Placebo - SC
    Administered SC.
Study Arms  ICMJE
  • Experimental: Ramucirumab - Intravenous (IV)
    Ramucirumab administered IV.
    Intervention: Drug: Ramucirumab - IV
  • Placebo Comparator: Placebo - IV
    Placebo administered IV.
    Intervention: Drug: Placebo - IV
  • Experimental: Ramucirumab - Subcutaneous (SC)
    Ramucirumab administered SC.
    Intervention: Drug: Ramucirumab - SC
  • Placebo Comparator: Placebo - SC
    Placebo administered SC.
    Intervention: Drug: Placebo - SC
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: July 30, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 9, 2021
Estimated Primary Completion Date May 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
  • Have a body weight greater than or equal to (≥)70 kilograms (kg) and body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m ²), inclusive
  • Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

  • Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
  • Have previously participated or withdrawn from this study
  • Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
  • Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04495478
Other Study ID Numbers  ICMJE 17748
I4T-MC-JVDT ( 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
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 February 15, 2021

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