Back to results

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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

suspension IR

CR 1

CR 2

CR 3

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Pharmacokinetics Immediate Release Oral Suspension Controlled Release Formulation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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).

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

50 mg oral suspension

50 mg CR Type 1

50 mg CR Type 2

50 mg SR Type 3

Arm Description

once daily for one day

Outcomes

Primary Outcome Measures

Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC.

Secondary Outcome Measures

Safety laboratory testing including: blood electrolytes and liver and kidney function-related chemistries, complete blood counts, urinalysis, and electrocardiogram

Other safety parameters including: physical examination and vital signs.

Adverse Event Reporting as reported by subject and through investigator query and categorized by MedRA terminology.

Full Information

NCT ID

NCT00782600

First Posted

October 27, 2008

Last Updated

June 5, 2009

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00782600

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Pharmacokinetics Immediate Release Oral Suspension Controlled Release Formulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50 mg oral suspension

Arm Type

Experimental

Arm Description

once daily for one day

Arm Title

50 mg CR Type 1

Arm Type

Experimental

Arm Description

once daily for one day

Arm Title

50 mg CR Type 2

Arm Type

Experimental

Arm Description

once daily for one day

Arm Title

50 mg SR Type 3

Arm Type

Experimental

Arm Description

once daily for one day

Intervention Type

Drug

Intervention Name(s)

suspension IR

Intervention Description

50 mg IR suspension once daily for one day

Intervention Type

Drug

Intervention Name(s)

CR 1

Intervention Description

50 mg shorter release CR once daily for one day

Intervention Type

Drug

Intervention Name(s)

CR 2

Intervention Description

50 mg medium release CR once daily for one day

Intervention Type

Drug

Intervention Name(s)

CR 3

Intervention Description

longer release SR formulation once daily for one day

Primary Outcome Measure Information:

Title

Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC.

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Safety laboratory testing including: blood electrolytes and liver and kidney function-related chemistries, complete blood counts, urinalysis, and electrocardiogram

Time Frame

1 month

Title

Other safety parameters including: physical examination and vital signs.

Time Frame

1 month

Title

Adverse Event Reporting as reported by subject and through investigator query and categorized by MedRA terminology.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6341011&StudyName=Study%20of%20%20Controlled%20Release%20Formulations%20of%20CE-224%2C535%20Against%20the%20Immediate%20Release%20Formulation%20in%20Normal%20Volunteers

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs