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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00782600

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: suspension IR Drug: CR 1 Drug: CR 2 Drug: CR 3	Phase I

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Sinemet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Phase 1, Randomized, 4-Period, 4-Sequence Cross-Over Study Of The Pharmacokinetics Of 3 Durations Of Release Of A Controlled Release Formulation And A Single Dose Of An Immediate Release Oral Suspension Of CE-224,535 In Normal Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:

Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety laboratory testing including: blood electrolytes and liver and kidney function-related chemistries, complete blood counts, urinalysis, and electrocardiogram [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Other safety parameters including: physical examination and vital signs. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Adverse Event Reporting as reported by subject and through investigator query and categorized by MedRA terminology. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	July 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
50 mg CR Type 1: Experimental once daily for one day	Drug: CR 1 50 mg shorter release CR once daily for one day
50 mg oral suspension: Experimental once daily for one day	Drug: suspension IR 50 mg IR suspension once daily for one day
50 mg CR Type 2: Experimental once daily for one day	Drug: CR 2 50 mg medium release CR once daily for one day
50 mg SR Type 3: Experimental once daily for one day	Drug: CR 3 longer release SR formulation once daily for one day

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782600

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6341011
Study First Received:	October 27, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00782600
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pharmacokinetics Immediate Release Oral Suspension Controlled Release Formulation

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Sinemet
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Healthy
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009