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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.
First Received: January 23, 2009   Last Updated: September 2, 2009   History of Changes
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00828646
  Purpose

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
Healthy
Drug: BMS-708163
Drug: Placebo
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentration [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

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
BMS-708163 - Panel 1: Experimental
(Age 20-45 years)
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
BMS-708163 - Panel 2: Experimental
(Age 20-45 years)
Drug: BMS-708163
Capsules, Oral, 100 mg/day, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
BMS-708163 - Panel 3: Experimental
(age 65 or above)
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
BMS-708163 - Panel 4: Experimental
(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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828646

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

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CN156-012
Study First Received: January 23, 2009
Last Updated: September 2, 2009
ClinicalTrials.gov Identifier: NCT00828646     History of Changes
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bristol-Myers Squibb:
Healthy Subjects

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on September 10, 2009