Healthy Volunteers
Conditions
Keywords
rheumatoid arthritis First in human safety pharmacokinetics pharmacodynamics
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.
Interventions
DRUGPF-04629991
Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy non-smoking men and women * body mass index 18-30 kg/m2
Exclusion criteria
* Women must not be able to have children * no current infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve | 2 weeks |
| Safety/Tolerability e.g., reported adverse events and safety laboratory studies | 2 weeks |
| Pharmacodynamics e.g., changes in a peripheral blood biomarker | 2 weeks |
Countries
Belgium
Outcome results
None listed