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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01772264
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : May 10, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-05089771 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: Arm A - active treatment Drug: PF-05089771
titration from 150mg BID to 450mg BID

Placebo Comparator: Arm B - placebo Drug: Placebo
matched placebo

Primary Outcome Measures :
  1. Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: 28 days ]
  2. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 12h ]
  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 12h ]

Secondary Outcome Measures :
  1. Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: 12h post dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01772264

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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer Identifier: NCT01772264    
Other Study ID Numbers: B3291018
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013