AzTrials
AzTrials

HealthyPhase 1JMADNCT00828646

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

A Phase 1 study testing BMS-708163 in people with Healthy, run by Bristol-Myers Squibb at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BMS-708163
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteJapan
Study dates
Oct 2008to Jul 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Local Institution

    Yokohama, Kanagawa, 2320064

Other trials in Japan

About this 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

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
Being tested
BMS-708163, Placebo
Keywords
Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-708163Drug

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

  • BMS-708163Drug

    Capsules, Oral, 100 mg/day, once daily, 14 days

  • BMS-708163Drug

    Capsules, Oral, 75 or 100 mg/day, once daily, 14 days

  • PlaceboDrug

    Capsules, Oral, once daily, 14 days

Study groups in NCT00828646
Study groupRoleWhat they receive
BMS-708163 - Panel 1Experimental(Age 20-45 years)
Receives: Drug: BMS-708163; Drug: Placebo
BMS-708163 - Panel 2Experimental(Age 20-45 years)
Receives: Drug: BMS-708163; Drug: Placebo
BMS-708163 - Panel 3Experimental(age 65 or above)
Receives: Drug: BMS-708163; Drug: Placebo
BMS-708163 - Panel 4Experimental(age 65 or above)
Receives: Drug: BMS-708163; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

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

Secondary outcomes (1)

  1. Plasma concentration

    Measured: Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00828646
Sponsor's protocol ID
CN156-012
Acronym
JMAD
Status last verified
Mar 2009
First submitted
23 Jan 2009
Last updated
7 Jan 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-708163 in people with Healthy, run by Bristol-Myers Squibb at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Within 30 days after the follow-up evaluation on Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00828646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in