Safety And Tolerability Study Of BID Titration Scheme With PF-05089771
- Registration Number
- NCT01772264
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B - placebo Placebo - Arm A - active treatment PF-05089771 -
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) 12h 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
- Secondary Outcome Measures
Name Time Method Minimum Observed Plasma Trough Concentration (Cmin) 12h post dose
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States