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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: suspension IR
* Drug: CR 1
* Drug: CR 2
* Drug: CR 3


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg oral suspension<br>once daily for one day | Drug: suspension IR<br>* 50 mg IR suspension once daily for one day<br>|
| Experimental: 50 mg CR Type 1<br>once daily for one day | Drug: CR 1<br>* 50 mg shorter release CR once daily for one day<br>|
| Experimental: 50 mg CR Type 2<br>once daily for one day | Drug: CR 2<br>* 50 mg medium release CR once daily for one day<br>|
| Experimental: 50 mg SR Type 3<br>once daily for one day | Drug: CR 3<br>* longer release SR formulation once daily for one day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics Immediate Release Oral Suspension Controlled Release Formulation