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Trial record 4 of 5 for:    PF-06410293

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01870986
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: PF-06410293 Biological: Humira (adalimumab-EU) Biological: Humira (adalimumab-US) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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 Name: 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 Name: 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 Name: adalimumab (United States)




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

Secondary Outcome Measures :
  1. Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab) [ Time Frame: Day 1 - Day 71 ]
  2. Time to Reach Maximum Observed Serum Concentration (Tmax) [ Time Frame: Day 1- Day 43 ]
  3. Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing [ Time Frame: Day 1- Day 43 ]
  4. Systemic Clearance (CL) [ Time Frame: Day 1- Day 43 ]
  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870986


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Belgium
Pfizer Investigational Site
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01870986    
Other Study ID Numbers: B5381001
REFLECTIONS B538-01
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014
Keywords provided by Pfizer:
Healthy Volunteers
Phase 1
PK
adalimumab
Single-dose
Immunology
Bioequivalence
Biosimilarity
Similarity.
Additional relevant MeSH terms:
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Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents