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

Pfizer1 site in 1 country210 target enrollmentMay 2013

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 210
Locations: 1
Primary Endpoint: Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

February 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)

Time Frame: Day 1 - Day 43

Maximum Observed Serum Concentration (Cmax)

Time Frame: 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

Secondary Outcomes

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)