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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00782600
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : June 9, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: suspension IR Drug: CR 1 Drug: CR 2 Drug: CR 3 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 50 mg oral suspension
once daily for one day
Drug: suspension IR
50 mg IR suspension once daily for one day
Experimental: 50 mg CR Type 1
once daily for one day
Drug: CR 1
50 mg shorter release CR once daily for one day
Experimental: 50 mg CR Type 2
once daily for one day
Drug: CR 2
50 mg medium release CR once daily for one day
Experimental: 50 mg SR Type 3
once daily for one day
Drug: CR 3
longer release SR formulation once daily for one day

Primary Outcome Measures :
  1. Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC. [ Time Frame: 1 month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00782600

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00782600     History of Changes
Other Study ID Numbers: A6341011
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: June 9, 2009
Last Verified: June 2009

Keywords provided by Pfizer:
Pharmacokinetics Immediate Release Oral Suspension Controlled Release Formulation

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases