A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07)) (B538-07)

• ClinicalTrials.gov Identifier: NCT02237729
• Recruitment Status: Completed
• First Posted: September 11, 2014
• Last Update Posted: April 13, 2015
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: September 9, 2014
• First Posted Date: September 11, 2014
• Last Update Posted Date: April 13, 2015
• Study Start Date: September 2014
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 9, 2014)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 9, 2014)

• 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
• Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) [ Time Frame: Day 1- Day 71 ]
  Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
• 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
• 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
• 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
• 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
• time to reach the maximum concentration (Tmax) [ Time Frame: Day 1 - Day 50 ]
  time to reach the maximum concentration (Tmax)
• Apparent clearance (CL/F) [ Time Frame: Day 1 - Day 50 ]
  Apparent clearance (CL/F)
• Apparent volume of distribution (Vz/F) [ Time Frame: Day 1 - Day 50 ]
  Apparent volume of distribution (Vz/F)
• Terminal half-life (T1/2) [ Time Frame: Day 1 - Day 50 ]
  Terminal half-life (T1/2)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS 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
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Basic Science
• Condition: Healthy Subjects

Intervention

• Biological: PF-06410293
  PF-06410293 will be administered as a single 40 mg, subcutaneous dose
  Other Name: Adalimumab-Pfizer
• Biological: Adalimumab-US
  Adalimumab-US 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

Study Arms

• Experimental: PF-06410293
  Intervention: Biological: PF-06410293
• Active Comparator: Adalimumab-US
  Intervention: Biological: Adalimumab-US
• Active Comparator: Adalimumab-EU
  Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
  Intervention: Biological: Adalimumab-EU

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 10, 2015): 362
• Original Estimated Enrollment (submitted: September 9, 2014): 285
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02237729
• Other Study ID Numbers: B5381007; REFLECTIONS B538-07
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2015