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Completed

NCT Number: NCT01226693

A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804

There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS.

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female subjects of non-childbearing potential between the ages of 21 and 55.
  • No evidence of active or latent TB.
  • An informed consent document signed and dated by the subject.

Exclusion criteria

  • Evidence, including abnormal clinical laboratory parameters, eg, liver enzyme elevations, or a history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy) or any active GI disease (including any relevant surgery).
  • Any current and clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3. A clinically significant skin lesion is defined as Grade 1 (mild) for rash and pruritus, and Grade 2 (moderate) or above for all other lesions (see Short Name description in CTCAE for specific description of lesion).
  • Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Treatment and study plan

PH-797804 material sparing tablet

Drug

oral, 6mg, single dose

PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug

oral, 6mg, single dose

PH-797804 Phase2b/3 without sodium lauryl sulphate

Drug

oral, 6mg, single dose

Primary outcomes

  1. Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)

    Time frame: predose to day 7 of treatment period

  2. Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)

    Time frame: predose to day 7 of treatment period

  3. Maximum observed concentration within the dosing interval (Cmax)

    Time frame: predose to day 7 of treatment period

  4. Time for Cmax (Tmax)

    Time frame: predose to day 7 of treatment period

  5. Terminal half-life (t1/2)

    Time frame: predose to day 7 of treatment period

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Open Label, Single Dose, 3 Treatment, Two Period, Balanced Incomplete Block Study In Healthy Fasted Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of A 6 Mg Dose Of The PH-797804 Material Sparing Tablet (MST) And Two Modified Versions Of The MST Formulation With And Without The Solubilizing Agent Sodium Lauryl Sulphate (SLS)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 22, 2010
Registry last updated
Mar 10, 2011

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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