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NCT Number: NCT01166555

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

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

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Key information

Conditions

Healthy Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-04236921

Drug

single subcutaneous dose

Primary outcomes

  1. Incidence and severity of adverse events

    Time frame: 5 months

  2. Incidence and severity of clinical findings on physical examination

    Time frame: 5 months

  3. Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements

    Time frame: 5 months

  4. Mean change from baseline in 12-lead electrocardiogram (ECG) parameters: PRI, RR, QRS, QT, QTcF (Freidericia's correction) and HR (heart rate)

    Time frame: 5 months

  5. Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters

    Time frame: 5 months

Secondary outcomes

  1. Incidence and severity of clinical laboratory abnormalities including absolute neturophil count, hepatic transaminases and bilirubin levels, and lipid profiles

    Time frame: 5 months

  2. Incidence and level of ADA development

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase I Pharmacokinetics And Tolerability Of PF-04236921 Following Subcutaneous Administration To Healthy Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 21, 2010
Registry last updated
Nov 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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