Safety Study of Multiple-dose of Gamma-secretase Inhibitor in Healthy Male Japanese and Healthy Elderly Japanese

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following 14-day multiple oral doses BMS-708163 in healthy young male Japanese and healthy elderly male and female Japanese subjects

Official Title
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Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 in Healthy Male Japanese Subjects and a Comparison to Healthy Elderly Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: BMS-708163
* Drug: BMS-708163
* Drug: BMS-708163
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Body Mass Index (BMI) of 19 to 25 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2 Men, ages 20 to 45, and men and women [not of childbearing potential (i.e., who are postmenopausal or surgically sterile)], ages 65 or older. Women are considered surgically sterile only if they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. Women are considered postmenopausal only if they have had amenorrhea for ≥12 consecutive months, or for women on hormone replacement therapy (HRT), if they have a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL Exclusion Criteria: WOCBP Women who are pregnant or breastfeeding Women with a positive pregnancy test on enrollment or prior to administration of investigational product Sexually active fertile men not using effective birth control if their partners are WOCBP Any significant acute or chronic medical illness Any current or recent? medical history of gastrointestinal disease that may affect evaluation of study treatment History of recent major surgery or gastrointestinal surgery that may impact on evaluation or absorption of study drug History of blood donation or blood transfusion within 4 weeks prior to the study treatment Intolerance to oral medication or venous access QTc interval (Bazett's correction) >500 ms at screening Smoking more than 10 cigarettes per day Recent (within 6 months) drug or alcohol abuse as defined in DSM IV Any other sound medical, psychiatric and/or social reason as determined by the investigator Subjects ≥ 65 yr are allowed to have age-related minimum or mild abnormalities in vital sign (i.e. blood pressure) or laboratory tests (i.e. blood sugar, serum cholesterol, or serum triglyceride) as far as they are not deemed signs or consequences of illness or organ dysfunction and a subject of medical treatment Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations Positive urine screen for drugs of abuse Positive blood screen for hepatitis C antibody, or HIV or hepatitis B antigen Indicators of abnormal renal function at baseline: any urine protein History of allergy to Gamma-Secretase Inhibitor or related compounds History of any significant drug allergy Prior exposure to BMS-708163 Exposure to any investigational drug or placebo within 4 weeks of study drug administration Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration Use of any other drugs, including over-the-counter medications and herbal preparations, within 2 weeks prior to study drug administration Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Ages Eligible for Study
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Minimum Age: 20 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-708163 - Panel 1<br>(Age 20-45 years) | Drug: BMS-708163<br>* Capsules, Oral, 50 mg, once daily, 14 days<br>Drug: Placebo<br>* Capsules, Oral, once daily, 14 days<br>|
| Experimental: BMS-708163 - Panel 2<br>(Age 20-45 years) | Drug: BMS-708163<br>* Capsules, Oral, 100 mg/day, once daily, 14 days<br>Drug: Placebo<br>* Capsules, Oral, once daily, 14 days<br>|
| Experimental: BMS-708163 - Panel 3<br>(age 65 or above) | Drug: BMS-708163<br>* Capsules, Oral, 50 mg, once daily, 14 days<br>Drug: Placebo<br>* Capsules, Oral, once daily, 14 days<br>|
| Experimental: BMS-708163 - Panel 4<br>(age 65 or above) | Drug: BMS-708163<br>* Capsules, Oral, 75 or 100 mg/day, once daily, 14 days<br>Drug: Placebo<br>* Capsules, Oral, once daily, 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Within 30 days after the follow-up evaluation on Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration |  | Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Subjects