Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)

February 13, 2014 updated by: Pfizer

Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects

This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

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

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Investigational Site
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.

Exclusion Criteria:

  • Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
PF-06410293
Biological: PF-06410293
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
Other Names:
  • adalimumab-Pfizer
Active Comparator: B
Adalimumab-EU
Biological: Humira (adalimumab-EU)
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
Other Names:
  • adalimumab (European Union)
Active Comparator: C
Adalimumab-US
Biological: Humira (adalimumab-US)
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
Other Names:
  • adalimumab (United States)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Serum Concentration (Cmax)
Time Frame: Day 1 - Day 43
Day 1 - Day 43
Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast)
Time Frame: Day 1 - Day 43
Day 1 - Day 43
Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)
Time Frame: Day 1 - Day 43
Day 1 - Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)
Time Frame: Day 1 - Day 71
Day 1 - Day 71
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time Frame: Day 1- Day 43
Day 1- Day 43
Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing
Time Frame: Day 1- Day 43
Day 1- Day 43
Systemic Clearance (CL)
Time Frame: Day 1- Day 43
Day 1- Day 43
Serum Decay Half-Life (t1/2)
Time Frame: Day 1- Day 43
Serum decay half-life is teh time for the serum concentration to decrease by one half
Day 1- Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

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.

Helpful Links

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

May 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 13, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B5381001
  • REFLECTIONS B538-01

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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