Pharmacokinetics And Tolerability Of Subcutaneous Administration Of PF 04236921 In Healthy Volunteers
- Registration Number
- NCT01166555
- Lead Sponsor
- Pfizer
- Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.
- Detailed Description
Tolerability and Pharmacokinetics of subcutaneously administered dose of PF-04236921 in healthy volunteers
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 PF-04236921 -
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events 5 months Incidence and severity of clinical findings on physical examination 5 months Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements 5 months Mean change from baseline in 12-lead electrocardiogram (ECG) parameters: PRI, RR, QRS, QT, QTcF (Freidericia's correction) and HR (heart rate) 5 months Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters 5 months
- Secondary Outcome Measures
Name Time Method Incidence and severity of clinical laboratory abnormalities including absolute neturophil count, hepatic transaminases and bilirubin levels, and lipid profiles 5 months Incidence and level of ADA development 5 months
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Bruxelles, Belgium