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

NCT ID: NCT01226693

Last Updated: 2011-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence 1

Group Type EXPERIMENTAL

PH-797804 material sparing tablet

Intervention Type DRUG

oral, 6mg, single dose

PH-797804 Phase2b/3 with sodium lauryl sulphate

Intervention Type DRUG

oral, 6mg, single dose

Sequence 2

Group Type EXPERIMENTAL

PH-797804 Phase2b/3 with sodium lauryl sulphate

Intervention Type DRUG

oral, 6mg, single dose

PH-797804 material sparing tablet

Intervention Type DRUG

oral, 6mg, single dose

Sequence 3

Group Type EXPERIMENTAL

PH-797804 material sparing tablet

Intervention Type DRUG

oral, 6mg, single dose

PH-797804 Phase2b/3 without sodium lauryl sulphate

Intervention Type DRUG

oral, 6mg, single dose

Sequence 4

Group Type EXPERIMENTAL

PH-797804 Phase2b/3 without sodium lauryl sulphate

Intervention Type DRUG

oral, 6mg, single dose

PH-797804 material sparing tablet

Intervention Type DRUG

oral, 6mg, single dose

Sequence 5

oral, 6mg, single dose

Group Type EXPERIMENTAL

PH-797804 Phase2b/3 without sodium lauryl sulphate

Intervention Type DRUG

oral, 6mg, single dose

PH-797804 Phase2b/3 with sodium lauryl sulphate

Intervention Type DRUG

oral, 6mg, single dose

Sequence 6

oral, 6mg, single dose

Group Type EXPERIMENTAL

PH-797804 Phase2b/3 with sodium lauryl sulphate

Intervention Type DRUG

oral, 6mg, single dose

PH-797804 Phase2b/3 without sodium lauryl sulphate

Intervention Type DRUG

oral, 6mg, single dose

Interventions

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PH-797804 material sparing tablet

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 Phase2b/3 with sodium lauryl sulphate

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 Phase2b/3 with sodium lauryl sulphate

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 material sparing tablet

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 material sparing tablet

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 Phase2b/3 without sodium lauryl sulphate

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 Phase2b/3 without sodium lauryl sulphate

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 material sparing tablet

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 Phase2b/3 without sodium lauryl sulphate

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 Phase2b/3 with sodium lauryl sulphate

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 Phase2b/3 with sodium lauryl sulphate

oral, 6mg, single dose

Intervention Type DRUG

PH-797804 Phase2b/3 without sodium lauryl sulphate

oral, 6mg, single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631028&StudyName=A%20Study%20In%20Healthy%20Volunteers%20To%20Assess%20The%20Safety%2C%20Tolerability%2C%20And%20Relative%20Oral%20Bioavailability%20Of%20Three%20Formulations%20Of%20PH-797804

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6631028

Identifier Type: -

Identifier Source: org_study_id

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