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

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
      • Miami, Florida, United States, 33126
        • SeaView Research, Inc.
      • Miami, Florida, United States, 33134
        • SeaView Reseach Screening Office
      • 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:
  • Adalimumab-Pfizer
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

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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