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

NCT ID: NCT00828646

Last Updated: 2011-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-07-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BMS-708163 - Panel 1

(Age 20-45 years)

Group Type: EXPERIMENTAL

BMS-708163

Intervention Type: DRUG

Capsules, Oral, 50 mg, once daily, 14 days

Placebo

Intervention Type: DRUG

Capsules, Oral, once daily, 14 days

BMS-708163 - Panel 2

(Age 20-45 years)

Group Type: EXPERIMENTAL

BMS-708163

Intervention Type: DRUG

Capsules, Oral, 100 mg/day, once daily, 14 days

Placebo

Intervention Type: DRUG

Capsules, Oral, once daily, 14 days

BMS-708163 - Panel 3

(age 65 or above)

Group Type: EXPERIMENTAL

BMS-708163

Intervention Type: DRUG

Capsules, Oral, 50 mg, once daily, 14 days

Placebo

Intervention Type: DRUG

Capsules, Oral, once daily, 14 days

BMS-708163 - Panel 4

(age 65 or above)

Group Type: EXPERIMENTAL

BMS-708163

Intervention Type: DRUG

Capsules, Oral, 75 or 100 mg/day, once daily, 14 days

Placebo

Intervention Type: DRUG

Capsules, Oral, once daily, 14 days

Interventions

BMS-708163

Capsules, Oral, 50 mg, once daily, 14 days

Intervention Type: DRUG

BMS-708163

Capsules, Oral, 100 mg/day, once daily, 14 days

Intervention Type: DRUG

BMS-708163

Capsules, Oral, 75 or 100 mg/day, once daily, 14 days

Intervention Type: DRUG

Placebo

Capsules, Oral, once daily, 14 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Bristol-Myers Squibb

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Yokohama, Kanagawa, Japan

Countries

Japan

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CN156-012

Identifier Type: -

Identifier Source: org_study_id