Healthy
Conditions
Keywords
Safety and tolerability, Pharmacokinetics, PF-04236921, Rheumatoid Arthritis
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
Interventions
DRUGPF-04236921
single subcutaneous dose
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of clinical findings on physical examination | 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 |
| Incidence and severity of adverse events | 5 months |
| Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements | 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and level of ADA development | 5 months |
| Incidence and severity of clinical laboratory abnormalities including absolute neturophil count, hepatic transaminases and bilirubin levels, and lipid profiles | 5 months |
Countries
Belgium
Outcome results
None listed