- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02237729
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07)) (B538-07)
April 10, 2015 updated by: Pfizer
Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
362
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
-
-
Florida
-
Coral Gables, Florida, United States, 33134
- De La Pedraja Radiology Associates
-
Jacksonville, Florida, United States, 32256
- SeaView Jacksonville
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Miami, Florida, United States, 33126
- SeaView Research, Inc.
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Miami, Florida, United States, 33134
- SeaView Reseach Screening Office
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Miami, Florida, United States, 33134
- SeaView Research, Inc. (Screening Office)
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- Vince & Associates Clinical Research, Inc.
-
Overland Park, Kansas, United States, 66211
- Vince & Associates Clinical Research, Inc.
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55114
- Prism research, LLC
-
-
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 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight >60 kg (132 lbs).
- Chest X ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PF-06410293
|
PF-06410293 will be administered as a single 40 mg, subcutaneous dose
Other Names:
|
ACTIVE_COMPARATOR: Adalimumab-US
|
Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
|
ACTIVE_COMPARATOR: Adalimumab-EU
Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
|
Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximal serum concentration (Cmax)
Time Frame: Day 1 - Day 50
|
maximal serum concentration (Cmax)
|
Day 1 - Day 50
|
area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)
Time Frame: 0-336 hours
|
area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)
|
0-336 hours
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]
Time Frame: Day 1 - Day 50
|
AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T)
|
Day 1 - Day 50
|
AUC extrapolated to infinity (AUC0inf)
Time Frame: Day 1 - Day 50
|
AUC extrapolated to infinity (AUC0inf)
|
Day 1 - Day 50
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
Time Frame: Day 1- Day 71
|
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
|
Day 1- Day 71
|
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
Time Frame: Day 1- Day 71
|
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
|
Day 1- Day 71
|
maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
Time Frame: Day 1 - Day 50
|
maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
|
Day 1 - Day 50
|
area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US
Time Frame: 0-336 hours
|
area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US
|
0-336 hours
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US
Time Frame: Day 1 - Day 50
|
AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) for adalimumab EU as compared to adalimumab US
|
Day 1 - Day 50
|
AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US
Time Frame: Day 1 - Day 50
|
AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US
|
Day 1 - Day 50
|
time to reach the maximum concentration (Tmax)
Time Frame: Day 1 - Day 50
|
time to reach the maximum concentration (Tmax)
|
Day 1 - Day 50
|
Apparent clearance (CL/F)
Time Frame: Day 1 - Day 50
|
Apparent clearance (CL/F)
|
Day 1 - Day 50
|
Apparent volume of distribution (Vz/F)
Time Frame: Day 1 - Day 50
|
Apparent volume of distribution (Vz/F)
|
Day 1 - Day 50
|
Terminal half-life (T1/2)
Time Frame: Day 1 - Day 50
|
Terminal half-life (T1/2)
|
Day 1 - Day 50
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2014
Primary Completion (ACTUAL)
March 1, 2015
Study Completion (ACTUAL)
March 1, 2015
Study Registration Dates
First Submitted
September 9, 2014
First Submitted That Met QC Criteria
September 9, 2014
First Posted (ESTIMATE)
September 11, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
April 13, 2015
Last Update Submitted That Met QC Criteria
April 10, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B5381007
- REFLECTIONS B538-07
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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