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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166555
• Other study ID #: B0151004
• Secondary ID: EudraCT 2010-019
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2010
• Last updated: November 19, 2010
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-04236921
single subcutaneous dose

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events		5 months	Yes
Primary	Incidence and severity of clinical findings on physical examination		5 months	Yes
Primary	Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements		5 months	Yes
Primary	Mean change from baseline in 12-lead electrocardiogram (ECG) parameters: PRI, RR, QRS, QT, QTcF (Freidericia's correction) and HR (heart rate)		5 months	Yes
Primary	Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters		5 months	No
Secondary	Incidence and severity of clinical laboratory abnormalities including absolute neturophil count, hepatic transaminases and bilirubin levels, and lipid profiles		5 months	Yes
Secondary	Incidence and level of ADA development		5 months	Yes

External Links

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