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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: suspension IR; Drug: CR 1; Drug: CR 2; Drug: CR 3

• Registration Number: NCT00782600
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2008-10-27
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-05
• Last Update Posted: 2009-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
50 mg oral suspension	suspension IR	once daily for one day
50 mg CR Type 1	CR 1	once daily for one day
50 mg CR Type 2	CR 2	once daily for one day
50 mg SR Type 3	CR 3	once daily for one day

Primary Outcome Measures

Name	Time	Method
Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC.	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States