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

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: January 23, 2009
Last updated: January 6, 2011
Last verified: March 2009
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

Condition Intervention Phase
Drug: BMS-708163
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Within 30 days after the follow-up evaluation on Day 28 ]

Secondary Outcome Measures:
  • Plasma concentration [ Time Frame: Day 21 ]

Enrollment: 32
Study Start Date: October 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-708163 - Panel 1
(Age 20-45 years)
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
Experimental: BMS-708163 - Panel 2
(Age 20-45 years)
Drug: BMS-708163
Capsules, Oral, 100 mg/day, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
Experimental: BMS-708163 - Panel 3
(age 65 or above)
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
Experimental: BMS-708163 - Panel 4
(age 65 or above)
Drug: BMS-708163
Capsules, Oral, 75 or 100 mg/day, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

  • 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
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Please refer to this study by its identifier: NCT00828646

Local Institution
Yokohama, Kanagawa, Japan, 2320064
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00828646     History of Changes
Other Study ID Numbers: CN156-012
Study First Received: January 23, 2009
Last Updated: January 6, 2011

Keywords provided by Bristol-Myers Squibb:
Healthy Subjects processed this record on May 25, 2017