A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
1 other identifier
interventional
145
1 country
6
Brief Summary
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2014
Shorter than P25 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
June 20, 2017
CompletedJune 20, 2017
April 1, 2017
2 months
June 13, 2014
November 8, 2016
April 6, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
60 days
Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
60 days
Secondary Outcomes (1)
Immunogenicity
60 days
Study Arms (2)
Brodalumab (single 1.5mL pre-filled syringe)
EXPERIMENTALA single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection
Brodalumab (2 pre-filled syringes [1.0mL + 0.5mL])
EXPERIMENTALA single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections
Interventions
Brodalumab is a large molecule for the treatment of inflammatory diseases
Eligibility Criteria
You may qualify if:
- healthy males and females with a BMI between 18.0 and 30.0 kg/m2, inclusive. Females must be of non-reproductive potential
You may not qualify if:
- no history or evidence of clinically significant disorder that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Research Site
Glendale, California, 91206, United States
Research Site
Aventura, Florida, 33180, United States
Research Site
Saint Paul, Minnesota, 55114, United States
Research Site
Lincoln, Nebraska, 68502, United States
Research Site
Austin, Texas, 78744, United States
Research Site
San Antonio, Texas, 78209, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Valeant Pharmaceuticals
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2014
First Posted
June 25, 2014
Study Start
September 1, 2014
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
June 20, 2017
Results First Posted
June 20, 2017
Record last verified: 2017-04