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

Pfizer10 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PF-04236921DRUG

single subcutaneous dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Incidence and severity of adverse events

Time frame: 5 months

Incidence and severity of clinical findings on physical examination

Time frame: 5 months

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

Time frame: 5 months

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

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

Time frame: 5 months

Secondary Outcomes

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

Time frame: 5 months

Incidence and level of ADA development

Time frame: 5 months

Data from ClinicalTrials.gov

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