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Completed

NCT Number: NCT01772264

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-05089771

Drug

titration from 150mg BID to 450mg BID

Placebo

Drug

matched placebo

Primary outcomes

  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 outcomes

  1. Minimum Observed Plasma Trough Concentration (Cmin)

    Time frame: 12h post dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 21, 2013
Registry last updated
May 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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