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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870986
• Other study ID #: B5381001
• Secondary ID: REFLECTIONS B538
• Status: Completed
• Phase: Phase 1
• First received: June 3, 2013
• Last updated: February 13, 2014
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• PF-06410293
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
• Humira (adalimumab-EU)
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
• Humira (adalimumab-US)
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brussels
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentration (Cmax)		Day 1 - Day 43	No
Primary	Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast)		Day 1 - Day 43	No
Primary	Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)		Day 1 - Day 43	No
Secondary	Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)		Day 1 - Day 71	Yes
Secondary	Time to Reach Maximum Observed Serum Concentration (Tmax)		Day 1- Day 43	No
Secondary	Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing		Day 1- Day 43	No
Secondary	Systemic Clearance (CL)		Day 1- Day 43	No
Secondary	Serum Decay Half-Life (t1/2)	Serum decay half-life is teh time for the serum concentration to decrease by one half	Day 1- Day 43	No

External Links

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