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History of Changes for Study: NCT02237729
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07)) (B538-07)
Latest version (submitted April 10, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 9, 2014 None (earliest Version on record)
2 October 9, 2014 Recruitment Status, Study Status, Contacts/Locations, Eligibility and Study Identification
3 November 6, 2014 Study Status
4 December 5, 2014 Study Status, Eligibility and Study Design
5 January 5, 2015 Study Status, Contacts/Locations and Study Identification
6 February 10, 2015 Study Status, Contacts/Locations and Study Identification
7 March 11, 2015 Study Status
8 April 10, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02237729
Submitted Date:  September 9, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: B5381007
Brief Title: A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07)) (B538-07)
Official Title: 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
Secondary IDs: REFLECTIONS B538-07
Open or close this module Study Status
Record Verification: September 2014
Overall Status: Not yet recruiting
Study Start: September 2014
Primary Completion: February 2015 [Anticipated]
Study Completion: March 2015 [Anticipated]
First Submitted: September 9, 2014
First Submitted that
Met QC Criteria:
September 9, 2014
First Posted: September 11, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 9, 2014
Last Update Posted: September 11, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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
Detailed Description:
Open or close this module Conditions
Conditions: Healthy Subjects
Keywords: healthy subjects
immunology
PK
Phase 1
bioequivalence
biosimilarity
adalimumab
single dose.
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 285 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PF-06410293 Biological: PF-06410293
PF-06410293 will be administered as a single 40 mg, subcutaneous dose
Other Names:
  • Adalimumab-Pfizer
Active Comparator: Adalimumab-US Biological: 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
Biological: Adalimumab-EU
Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
Open or close this module Outcome Measures
Primary Outcome Measures:
1. maximal serum concentration (Cmax)
[ Time Frame: Day 1 - Day 50 ]

maximal serum concentration (Cmax)
2. 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)
3. 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)
4. AUC extrapolated to infinity (AUC0inf)
[ Time Frame: Day 1 - Day 50 ]

AUC extrapolated to infinity (AUC0inf)
Secondary Outcome Measures:
1. 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
2. Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
[ Time Frame: Day 1- Day 71 ]

Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
3. 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
4. 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
5. 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
6. 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
7. time to reach the maximum concentration (Tmax)
[ Time Frame: Day 1 - Day 50 ]

time to reach the maximum concentration (Tmax)
8. Apparent clearance (CL/F)
[ Time Frame: Day 1 - Day 50 ]

Apparent clearance (CL/F)
9. Apparent volume of distribution (Vz/F)
[ Time Frame: Day 1 - Day 50 ]

Apparent volume of distribution (Vz/F)
10. Terminal half-life (T1/2)
[ Time Frame: Day 1 - Day 50 ]

Terminal half-life (T1/2)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations:
Open or close this module IPDSharing
Plan to Share IPD:

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