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

Healthy Clinical Trial

— JMAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828646
• Other study ID #: CN156-012
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2009
• Last updated: January 6, 2011
• Start date: October 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BMS-708163
Capsules, Oral, 50 mg, once daily, 14 days
• BMS-708163
Capsules, Oral, 100 mg/day, once daily, 14 days
• BMS-708163
Capsules, Oral, 75 or 100 mg/day, once daily, 14 days
• Placebo
Capsules, Oral, once daily, 14 days

Locations

Country	Name	City	State
Japan	Local Institution	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		Within 30 days after the follow-up evaluation on Day 28	Yes
Secondary	Plasma concentration		Day 21	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form