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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01772264
First received: January 17, 2013
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PF-05089771
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 12h ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 12h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: 12h post dose ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A - active treatment Drug: PF-05089771
titration from 150mg BID to 450mg BID
Placebo Comparator: Arm B - placebo Drug: Placebo
matched placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01772264

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01772264     History of Changes
Other Study ID Numbers: B3291018
Study First Received: January 17, 2013
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 19, 2014