- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381547
A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518) (Willow 2)
April 3, 2019 updated by: Eli Lilly and Company
An Open Label, Randomized, Single Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetics of Different Dose Levels and Dose Formulations of AM0010 in Healthy Adult Subjects
To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An open label, randomized, single dose, 3-way crossover study to evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78744
- Ppd Development
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female between 18 and 55 years of age, inclusive
- Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
- Must be HIV negative by HIV 1/0/2 testing
- Must be Hepatitis B (HBV) surface antigen negative
- Must be Hepatitis C (HCV) antibody negative
- Females must have a negative serum pregnancy test
- Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study dosing and for 30 days following the last dose of study drug.
- Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug
Exclusion Criteria:
- Pregnant or lactating subjects
- Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
- Have poor venous access and are unable to donate blood
- Have been vaccinated within 90 days of study dosing
- Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
- Have history of significant drug sensitivity or drug allergy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Pegilodecakin: Dose level depending on weight will be 0.8 mg or 1.6 mg, dose formulation 4 mg/mL.
|
Pegilodecakin Alone
Other Names:
|
Active Comparator: B
Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 4 mg/mL.
|
Pegilodecakin Alone
Other Names:
|
Active Comparator: C
Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 2 mg/mL.
|
Pegilodecakin Alone
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameters, Cmax
Time Frame: 43 days
|
maximal plasma concentration (Cmax)
|
43 days
|
Pharmacokinetic parameters, Tmax
Time Frame: 43 days
|
maximal concentration (Tmax)
|
43 days
|
Pharmacokinetic parameters, AUC
Time Frame: 43 days
|
area under the plasma concentration curve (AUC)
|
43 days
|
Pharmacokinetic parameters, CL/F
Time Frame: 43 days
|
clearance (CL/F).
|
43 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: 43 days
|
Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, and vital signs.
|
43 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2017
Primary Completion (Actual)
February 11, 2018
Study Completion (Actual)
February 11, 2018
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
December 18, 2017
First Posted (Actual)
December 22, 2017
Study Record Updates
Last Update Posted (Actual)
April 5, 2019
Last Update Submitted That Met QC Criteria
April 3, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 17298
- J1L-AM-JZGF (Other Identifier: Eli Lilly and Company)
- AM0010-802 (Other Identifier: ARMO BioSciences)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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