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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate; Drug: PH-797804 material sparing tablet; Drug: PH-797804 Phase2b/3 without sodium lauryl sulphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01226693

A6631028

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

Sequence 1

Experimental group

Treatment:

Drug: PH-797804 material sparing tablet

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 material sparing tablet

Drug: PH-797804 material sparing tablet

Drug: PH-797804 material sparing tablet

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Sequence 2

Experimental group

Treatment:

Drug: PH-797804 material sparing tablet

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 material sparing tablet

Drug: PH-797804 material sparing tablet

Drug: PH-797804 material sparing tablet

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Sequence 3

Experimental group

Treatment:

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

Drug: PH-797804 material sparing tablet

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

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

Drug: PH-797804 material sparing tablet

Drug: PH-797804 material sparing tablet

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

Drug: PH-797804 material sparing tablet

Sequence 4

Experimental group

Treatment:

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

Drug: PH-797804 material sparing tablet

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

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

Drug: PH-797804 material sparing tablet

Drug: PH-797804 material sparing tablet

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

Drug: PH-797804 material sparing tablet

Sequence 5

Experimental group

Description:

oral, 6mg, single dose

Treatment:

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

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

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

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

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

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Sequence 6

Experimental group

Description:

oral, 6mg, single dose

Treatment:

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

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

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

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

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

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate

Drug: PH-797804 Phase2b/3 with sodium lauryl sulphate