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

January 6, 2011 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 2320064
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BMS-708163 - Panel 1
(Age 20-45 years)
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 14 days
Drug: BMS-708163
Capsules, Oral, 100 mg/day, once daily, 14 days
Drug: BMS-708163
Capsules, Oral, 75 or 100 mg/day, 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, 50 mg, once daily, 14 days
Drug: BMS-708163
Capsules, Oral, 100 mg/day, once daily, 14 days
Drug: BMS-708163
Capsules, Oral, 75 or 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: BMS-708163
Capsules, Oral, 100 mg/day, once daily, 14 days
Drug: BMS-708163
Capsules, Oral, 75 or 100 mg/day, 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, 50 mg, once daily, 14 days
Drug: BMS-708163
Capsules, Oral, 100 mg/day, once daily, 14 days
Drug: BMS-708163
Capsules, Oral, 75 or 100 mg/day, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse Events
Time Frame: Within 30 days after the follow-up evaluation on Day 28
Within 30 days after the follow-up evaluation on Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Plasma concentration
Time Frame: Day 21
Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CN156-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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