NCT01226693

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 10, 2011

Status Verified

March 1, 2011

Enrollment Period

4 months

First QC Date

October 20, 2010

Last Update Submit

March 9, 2011

Conditions

Healthy

Keywords

pharmacokineticsingle dose bioequivalence studybalanced incomplete block designPH-797804P38 kinase inhibitor

Outcome Measures

Primary Outcomes (5)

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

    predose to day 7 of treatment period

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

    predose to day 7 of treatment period

  • Maximum observed concentration within the dosing interval (Cmax)

    predose to day 7 of treatment period

  • Time for Cmax (Tmax)

    predose to day 7 of treatment period

  • Terminal half-life (t1/2)

    predose to day 7 of treatment period

Study Arms (6)

Sequence 1

EXPERIMENTAL
Drug: PH-797804 material sparing tabletDrug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Sequence 2

EXPERIMENTAL
Drug: PH-797804 Phase2b/3 with sodium lauryl sulphateDrug: PH-797804 material sparing tablet

Sequence 3

EXPERIMENTAL
Drug: PH-797804 material sparing tabletDrug: PH-797804 Phase2b/3 without sodium lauryl sulphate

Sequence 4

EXPERIMENTAL
Drug: PH-797804 Phase2b/3 without sodium lauryl sulphateDrug: PH-797804 material sparing tablet

Sequence 5

EXPERIMENTAL

oral, 6mg, single dose

Drug: PH-797804 Phase2b/3 without sodium lauryl sulphateDrug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Sequence 6

EXPERIMENTAL

oral, 6mg, single dose

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphateDrug: PH-797804 Phase2b/3 without sodium lauryl sulphate

Interventions

PH-797804 material sparing tabletDRUG

oral, 6mg, single dose

Sequence 1
PH-797804 Phase2b/3 with sodium lauryl sulphateDRUG

oral, 6mg, single dose

Sequence 1
PH-797804 Phase2b/3 without sodium lauryl sulphateDRUG

oral, 6mg, single dose

Sequence 3

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Interventions

Sodium Dodecyl Sulfate

Intervention Hierarchy (Ancestors)

DodecanolFatty AlcoholsAlcoholsOrganic ChemicalsAlkanesulfonatesAlkanesulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 22, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 10, 2011

Record last verified: 2011-03

Locations

SG(1)