Pharmacokinetics And Tolerability Of Subcutaneous Administration Of PF 04236921 In Healthy Volunteers

NCT ID: NCT01166555

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-10-31

Brief Summary

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This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.

Detailed Description

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Tolerability and Pharmacokinetics of subcutaneously administered dose of PF-04236921 in healthy volunteers

Conditions

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Healthy

Keywords

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Safety and tolerability Pharmacokinetics PF-04236921 Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

PF-04236921

Intervention Type DRUG

single subcutaneous dose

Interventions

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PF-04236921

single subcutaneous dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males between 18-55 years, inclusive.
* Healthy females of non-childbearing potential between 18 and 55 years, inclusive.

Exclusion Criteria

* Evidence or history of clinically significant disease.
* Females of childbearing potential.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.

Reference Type DERIVED
PMID: 29776017 (View on PubMed)

Related Links

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Other Identifiers

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EudraCT 2010-019770-32

Identifier Type: -

Identifier Source: secondary_id

B0151004

Identifier Type: -

Identifier Source: org_study_id