Healthy
Conditions
Brief summary
The most notable tolerability finding from these multiple dosing studies has been the occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this finding, the current four week study is designed to examine whether a slow titration regimen up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.
Interventions
DRUGPF-05089771
titration from 150mg BID to 450mg BID
DRUGPlacebo
matched placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and/or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate
Exclusion criteria
* Evidence or history of clinically significant hematological, renal (ie, recurrent nephrolitisis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * History of, or presence of allergic skin reactions or active skin disease (except for subjects with acne who may be included in the study) at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) | 28 days |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | 12h |
| Maximum Observed Plasma Concentration (Cmax) | 12h |
Secondary
| Measure | Time frame |
|---|---|
| Minimum Observed Plasma Trough Concentration (Cmin) | 12h post dose |
Countries
United States
Outcome results
None listed