A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))

Healthy Subjects Clinical Trial

— B538-07  

Official title:

Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237729
• Other study ID #: B5381007
• Secondary ID: REFLECTIONS B538
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2014
• Last updated: April 10, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.

• Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight >60 kg (132 lbs).

• Chest X ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

• Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• PF-06410293
PF-06410293 will be administered as a single 40 mg, subcutaneous dose
• Adalimumab-US
Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
• Adalimumab-EU
Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose

Locations

Country	Name	City	State
United States	De La Pedraja Radiology Associates	Coral Gables	Florida
United States	SeaView Jacksonville	Jacksonville	Florida
United States	SeaView Reseach Screening Office	Miami	Florida
United States	SeaView Research, Inc.	Miami	Florida
United States	SeaView Research, Inc. (Screening Office)	Miami	Florida
United States	Vince & Associates Clinical Research, Inc.	Overland Park	Kansas
United States	Vince & Associates Clinical Research, Inc.	Overland Park	Kansas
United States	Prism Research, LLC	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal serum concentration (Cmax)	maximal serum concentration (Cmax)	Day 1 - Day 50	No
Primary	area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)	area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)	0-336 hours	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]	AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T)	Day 1 - Day 50	No
Primary	AUC extrapolated to infinity (AUC0inf)	AUC extrapolated to infinity (AUC0inf)	Day 1 - Day 50	No
Secondary	Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters	Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters	Day 1- Day 71	Yes
Secondary	Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)	Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)	Day 1- Day 71	No
Secondary	maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US	maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US	Day 1 - Day 50	No
Secondary	area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US	area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US	0-336 hours	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US	AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) for adalimumab EU as compared to adalimumab US	Day 1 - Day 50	No
Secondary	AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US	AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US	Day 1 - Day 50	No
Secondary	time to reach the maximum concentration (Tmax)	time to reach the maximum concentration (Tmax)	Day 1 - Day 50	No
Secondary	Apparent clearance (CL/F)	Apparent clearance (CL/F)	Day 1 - Day 50	No
Secondary	Apparent volume of distribution (Vz/F)	Apparent volume of distribution (Vz/F)	Day 1 - Day 50	No
Secondary	Terminal half-life (T1/2)	Terminal half-life (T1/2)	Day 1 - Day 50	No

External Links

•   To obtain contact information for a study center near you, click here.