Safety And Tolerability Study Of BID Titration Scheme With PF-05089771

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: 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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-21
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-10

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
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 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