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Type 2 Diabetes MellitusPhase 1NCT01515202

Japanese Phase 1 Multiple Ascending Dose Study

A Phase 1 study testing BMS-823778 in people with Type 2 Diabetes Mellitus, 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
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Trial summary

The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
BMS-823778
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteJapan
Study dates
Mar 2012to Sep 2012
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Japanese patients with Type 2 Diabetes Mellitus (T2DM) [Fasting glucose < 240 mg/dL, Hemoglobin A1c (HbA1c): 6.5% to 10.0% National Glycohemoglobin Standardization Program (NGSP)] who are treatment-naive and managed with diet and/or exercises only, ages: 20 to 65 years

Who cannot join

  • Patient who is taking any medication for T2DM
  • Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial
  • Insulin therapy within one year of screening

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Local Institution

    Hachioji-Shi, Tokyo, 1920071

Other trials in Japan

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blinded, Multiple Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-823778 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus.

Read the detailed description

MAD study - Multiple Ascending Dose study

Being tested
BMS-823778, Placebo matching with BMS-823778
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • BMS-823778Drug

    Capsules, Oral, 2 mg, Once daily, 14 days

  • BMS-823778Drug

    Capsules, Oral, 12 mg, Once daily, 14 days

  • BMS-823778Drug

    Capsules, Oral, 25 mg, Once daily, 14 days

  • BMS-823778Drug

    Capsules, Oral, 15 mg, Once daily, 14 days

  • Placebo matching with BMS-823778Drug

    Capsules, Oral, 0 mg, Once daily, 14 days

Study groups in NCT01515202
Study groupRoleWhat they receive
Panel 1: BMS-823778 or Placebo matching BMS-823778ExperimentalHealthy Subjects
Receives: Drug: BMS-823778; Drug: Placebo matching with BMS-823778
Panel 2: BMS-823778 or Placebo matching BMS-823778ExperimentalHealthy Subjects
Receives: Drug: BMS-823778; Drug: Placebo matching with BMS-823778
Panel 3: BMS-823778 or Placebo matching BMS-823778ExperimentalHealthy Subjects
Receives: Drug: BMS-823778; Drug: Placebo matching with BMS-823778
Panel 4: BMS-823778 or Placebo matching BMS-823778ExperimentalSubjects with T2DM
Receives: Drug: BMS-823778; Drug: Placebo matching with BMS-823778
Panel 5: BMS-823778 or Placebo matching BMS-823778ExperimentalSubjects with T2DM
Receives: Drug: BMS-823778; Drug: Placebo matching with BMS-823778

What is being measured

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

  1. Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests

    Measured: Up to Day 21

Secondary outcomes (12)

  1. Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  2. Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  3. Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  4. Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  5. Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  6. Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  7. Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  8. Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  9. Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  10. Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  11. Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration

    Measured: Up to Day 21

  12. Pharmacodynamics, as measured by Serum concentration of cortisol and cortisone after an oral dose of cortisone and biomarkers for HPA axis activity (urinary free cortisol and cortisone, salivary cortisol, ACTH, DHEA-S and 4-androstenedione)

    • HPA = Hypothalamic-pituitary-adrenal
    • DHEA-S = Dehydroepiandrosterone-sulphate
    • ACTH = adrenocorticotropic hormone

    Measured: Up to 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 posted24 Jan 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionSep 2012
  4. Study completionSep 2012

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01515202
Sponsor's protocol ID
MB121-009
Status last verified
Dec 2012
First submitted
18 Jan 2012
Last updated
5 Dec 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-823778 in people with Type 2 Diabetes Mellitus, 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 1 inclusion and 3 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 5 Dec 2012. 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?

Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests (time frame: Up to Day 21). 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 NCT01515202.

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 5 Dec 2012.

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