You are here

Our science / Clinical Trials / Find a Trial / NCT01870986

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

Back to Search Print Save as PDF Bookmark Trial

NCT01870986

Last updated on April 7, 2020
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01870986
Pfizer
Completed
Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Advanced Search

Based on your search, you may also be interested in

Hepatic Impairment, Healthy Participants
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
NCT04193436
All Genders
18+
Years
Multiple Sites
Healthy Volunteers
A Drug-Drug Interaction Study To Estimate The Effect Of Tafamidis On Rosuvastatin Pharmacokinetics
NCT04253353
All Genders
18+
Years
Brussels, Bruxelles-capitale, Région DE
Healthy Volunteer, Renal Impairment
Renal Impairment Study of PF-06700841
NCT04260464
All Genders
18+
Years
Saint Paul, Minnesota
Healthy Female Volunteers
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
NCT04267250
Females
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: PF-06410293
    40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
    Other Name: adalimumab-Pfizer
  • 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)
  • 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)
Study Arms  ICMJE
  • Experimental: A
    PF-06410293
    Intervention: Biological: PF-06410293
  • Active Comparator: B
    Adalimumab-EU
    Intervention: Biological: Humira (adalimumab-EU)
  • Active Comparator: C
    Adalimumab-US
    Intervention: Biological: Humira (adalimumab-US)
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2013) 		210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01870986
Other Study ID Numbers  ICMJE B5381001
REFLECTIONS B538-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now