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

Healthy Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226693
• Other study ID #: A6631028
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2010
• Last updated: March 9, 2011
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Heath Science Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PH-797804 material sparing tablet
oral, 6mg, single dose
• PH-797804 Phase2b/3 with sodium lauryl sulphate
oral, 6mg, single dose
• PH-797804 Phase2b/3 with sodium lauryl sulphate
oral, 6mg, single dose
• PH-797804 material sparing tablet
oral, 6mg, single dose
• PH-797804 material sparing tablet
oral, 6mg, single dose
• PH-797804 Phase2b/3 without sodium lauryl sulphate
oral, 6mg, single dose
• PH-797804 Phase2b/3 without sodium lauryl sulphate
oral, 6mg, single dose
• PH-797804 material sparing tablet
oral, 6mg, single dose
• PH-797804 Phase2b/3 without sodium lauryl sulphate
oral, 6mg, single dose
• PH-797804 Phase2b/3 with sodium lauryl sulphate
oral, 6mg, single dose
• PH-797804 Phase2b/3 with sodium lauryl sulphate
oral, 6mg, single dose
• PH-797804 Phase2b/3 without sodium lauryl sulphate
oral, 6mg, single dose

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)		predose to day 7 of treatment period	No
Primary	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	No
Primary	Maximum observed concentration within the dosing interval (Cmax)		predose to day 7 of treatment period	No
Primary	Time for Cmax (Tmax)		predose to day 7 of treatment period	No
Primary	Terminal half-life (t1/2)		predose to day 7 of treatment period	No

External Links

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