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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00782600
First received: October 27, 2008
Last updated: June 5, 2009
Last verified: June 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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
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

  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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00782600     History of Changes
Other Study ID Numbers: A6341011
Study First Received: October 27, 2008
Last Updated: June 5, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014