A Study of Ramucirumab (LY3009806) in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495478
• Other study ID #: 17748
• Secondary ID: I4T-MC-JVDT
• Status: Completed
• Phase: Phase 1
• Start date: July 30, 2020
• Est. completion date: May 9, 2021

Study information

• Verified date: May 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 9, 2021
• Est. primary completion date: May 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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• Have previously participated or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Ramucirumab - IV
Administered IV.
• Placebo - IV
Administered IV.
• Ramucirumab - SC
Administered SC.
• Placebo - SC
Administered SC.

Locations

Country	Name	City	State
United States	Covance Clinical Research Inc	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 90
Primary	Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug	Number of participants showing ISRs when the drug was administered subcutaneously were reported.	Day 1 Predose through Day 90
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of Ramucirumab	PK: AUC[0-8] of Ramucirumab.	1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose
Primary	PK: Maximum Concentration (Cmax) of Ramucirumab	PK: Cmax of Ramucirumab	1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose