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

NCT00828646 | Completed Phase 1

• 1 other identifier: CN156-012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Within 30 days after the follow-up evaluation on Day 28

Secondary Outcomes (1)

• Plasma concentration

  Day 21

Study Arms (4)

BMS-708163 - Panel 1

EXPERIMENTAL

(Age 20-45 years)

Drug: BMS-708163; Drug: Placebo

BMS-708163 - Panel 2

EXPERIMENTAL

(Age 20-45 years)

Drug: BMS-708163; Drug: Placebo

BMS-708163 - Panel 3

EXPERIMENTAL

(age 65 or above)

Drug: BMS-708163; Drug: Placebo

BMS-708163 - Panel 4

EXPERIMENTAL

(age 65 or above)

Drug: BMS-708163; Drug: Placebo

Interventions

BMS-708163 DRUG

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

BMS-708163 - Panel 1; BMS-708163 - Panel 3

Placebo DRUG

Capsules, Oral, once daily, 14 days

BMS-708163 - Panel 1; BMS-708163 - Panel 2; BMS-708163 - Panel 3; BMS-708163 - Panel 4

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Yokohama, Kanagawa, 2320064, Japan

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Interventions

BMS 708163

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 7, 2011

Record last verified: 2009-03

Locations

JP (1)