Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
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
2 other identifiers
interventional
210
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2013
Typical duration for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 3, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 14, 2014
February 1, 2014
9 months
June 3, 2013
February 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Observed Serum Concentration (Cmax)
Day 1 - Day 43
Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast)
Day 1 - Day 43
Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)
Day 1 - Day 43
Secondary Outcomes (5)
Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)
Day 1 - Day 71
Time to Reach Maximum Observed Serum Concentration (Tmax)
Day 1- Day 43
Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing
Day 1- Day 43
Systemic Clearance (CL)
Day 1- Day 43
Serum Decay Half-Life (t1/2)
Day 1- Day 43
Study Arms (3)
A
EXPERIMENTALPF-06410293
B
ACTIVE COMPARATORAdalimumab-EU
C
ACTIVE COMPARATORAdalimumab-US
Interventions
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Pfizer Investigational Site
Brussels, B-1070, Belgium
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2013
First Posted
June 6, 2013
Study Start
May 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 14, 2014
Record last verified: 2014-02