Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: CR 3; Drug: suspension IR; Drug: CR 1; Drug: CR 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782600

A6341011

Details and patient eligibility

About

This study is to test the idea that a controlled release formulation of CE-224,535 may allow for less frequent dosing and exposure to lower levels of drug than an immediate release formulation.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
• Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
• An informed consent document signed and dated by the subject or a legally acceptable representative.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
• Any conHistory of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
• condition possibly affecting drug absorption (eg, gastrectomy).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

50 mg oral suspension

Experimental group

Description:

once daily for one day

Treatment:

Drug: suspension IR

50 mg CR Type 1

Experimental group

Description:

once daily for one day

Treatment:

Drug: CR 1

50 mg CR Type 2

Experimental group

Description:

once daily for one day

Treatment:

Drug: CR 2

50 mg SR Type 3

Experimental group

Description:

once daily for one day

Treatment:

Drug: CR 3