Safety And Tolerability Study Of BID Titration Scheme With PF-05089771
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/30/2013 |
| Start Date: | January 2013 |
| End Date: | April 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
An Investigator And Subject Blinded, Sponsor Open, Randomized, Placebo Controlled, Multiple Dose Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-05089771 In Healthy Subjects
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.
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.
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