DiabetesPhase 1NCT01240980
Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)
A Phase 1 study testing BMS-903452 in people with Diabetes, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects \& relative bioavailability of the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 \& 12(Part A)] ; and subjects with type 2 Diabetes Mellitus (Part… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- BMS-903452
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Jan 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically healthy or Clinical diagnosis of Type 2 diabetes on a stable dose of metformin monotherapy
Who cannot join
- Type 1 Diabetes
- History of significant heart disease
- Prior bariatric surgery
- Women of childbearing potential
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ppd Development, Lp
Austin, Texas, 78744
Comprehensive Phase One
Miramar, Florida, 33025
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-903452 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects \& relative bioavailability of the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 \& 12(Part A)] ; and subjects with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of BMS-903452 in the blood.
- Conditions
- Diabetes
- Being tested
- BMS-903452, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-903452Drug
Solution, Oral, 0.1 mg, once daily, 1 day
BMS-903452Drug
Solution, Oral, 0.6 mg, once daily, 1 day
BMS-903452Drug
Suspension, Oral, 3.0 mg, once daily, 1 day
BMS-903452Drug
Suspension, Oral, 10 mg, once daily, 1 day
BMS-903452Drug
Suspension, Oral, 30 mg, once daily, 1 day
BMS-903452Drug
Suspension, Oral, 60 mg, once daily, 1 day
BMS-903452Drug
Suspension, Oral, 120 mg, once daily, 1 day
PlaceboDrug
Solution, Oral, 0 mg, once daily, 1 day
PlaceboDrug
Suspension, Oral, 0 mg, once daily, 1 day
BMS-903452Drug
Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
BMS-903452Drug
Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
PlaceboDrug
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
BMS-903452Drug
Solution, Oral, 0.6 mg, once daily, 1 day
BMS-903452Drug
Suspension, Oral, 10 mg, once daily, 1 day
BMS-903452Drug
Suspension, Oral, 120 mg, once daily, 1 day
| Study group | Role | What they receive |
|---|---|---|
| BMS-903452 (0.1 mg) or Placebo - A1 | Experimental | (Healthy Subjects) Receives: Drug: BMS-903452; Drug: Placebo |
| BMS-903452 (0.6 mg) or Placebo - A2 | Experimental | (Healthy Subjects) Receives: Drug: BMS-903452; Drug: Placebo |
| BMS-903452 (3.0 mg) or Placebo - A3 | Experimental | (Healthy Subjects) Receives: Drug: BMS-903452; Drug: Placebo |
| BMS-903452 (10 mg) or Placebo - A4 | Experimental | (Healthy Subjects) Receives: Drug: BMS-903452; Drug: Placebo |
| BMS-903452 (30 mg) or Placebo - A5 | Experimental | (Healthy Subjects) Receives: Drug: BMS-903452; Drug: Placebo |
| BMS-903452 (60 mg) or Placebo - A6 | Experimental | (Healthy Subjects) Receives: Drug: BMS-903452; Drug: Placebo |
| BMS-903452 (120 mg) or Placebo - A7 | Experimental | (Healthy Subjects) Receives: Drug: BMS-903452; Drug: Placebo |
| BMS-903452 (0.6 mg) or Placebo - B1 | Experimental | (Subjects with type 2 Diabetes Mellitus) Receives: Drug: Placebo; Drug: BMS-903452 |
| BMS-903452 (10 mg) or Placebo - B2 | Experimental | (Subjects with type 2 Diabetes Mellitus) Receives: Drug: Placebo; Drug: BMS-903452 |
| BMS-903452 (120 mg) or Placebo - B3 | Experimental | (Subjects with type 2 Diabetes Mellitus) Receives: Drug: Placebo; Drug: BMS-903452 |
| BMS-903452 (10 mg) or Placebo - A11 | Experimental | (Healthy Subjects) Receives: Drug: BMS-903452; Drug: Placebo |
| BMS-903452 (60 mg) or Placebo - A12 | Experimental | (Healthy Subjects) Receives: Drug: BMS-903452; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Measured: Within 10 days of study drug administration
Secondary outcomes (10)
Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism
Measured: Within 2 days of study drug administration
Effect on electrocardiographic (ECG) parameters
Measured: Within 10 days of study drug administration
Percent urinary recovery (% UR)
derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses
Measured: Within 10 days of study drug administration
Renal clearance (CLR) from plasma
derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses
Measured: Within 10 days of study drug administration
The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data
Measured: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter time to reach maximum observed concentration in plasma (Tmax) of BMS-903452 will be derived from the plasma concentration versus time data
Measured: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter time Area under the plasma concentration-time curve from time zero extrapolated to infinity AUC(INF) of BMS-903452 will be derived from the plasma concentration versus time data
Measured: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter Area under the plasma concentration-time curve from time zero to last measurable sampling time AUC (0-T) of BMS-903452 will be derived from the plasma concentration versus time data
Measured: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter Terminal-phase elimination half-life in plasma (T-Half) of BMS-903452 will be derived from the plasma concentration versus time data
Measured: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter apparent clearance from plasma after extra-vascular administration (CLT/F) of BMS-903452 will be derived from the plasma concentration versus time data
Measured: Within 10 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240980
- Sponsor's protocol ID
- MB125-001
- Status last verified
- Nov 2011
- First submitted
- 11 Nov 2010
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-903452 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01240980
- Acronym / sponsor ID
- MB125-001
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects \& relative bioavailability of the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 \& 12(Part A)] ; and subjects with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of BMS-903452 in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| BMS-903452 (0.1 mg) or Placebo - A1 | Experimental | Drug: BMS-903452, Drug: Placebo(Healthy Subjects) |
| BMS-903452 (0.6 mg) or Placebo - A2 | Experimental | Drug: BMS-903452, Drug: Placebo(Healthy Subjects) |
| BMS-903452 (3.0 mg) or Placebo - A3 | Experimental | Drug: BMS-903452, Drug: Placebo(Healthy Subjects) |
| BMS-903452 (10 mg) or Placebo - A4 | Experimental | Drug: BMS-903452, Drug: Placebo(Healthy Subjects) |
| BMS-903452 (30 mg) or Placebo - A5 | Experimental | Drug: BMS-903452, Drug: Placebo(Healthy Subjects) |
| BMS-903452 (60 mg) or Placebo - A6 | Experimental | Drug: BMS-903452, Drug: Placebo(Healthy Subjects) |
| BMS-903452 (120 mg) or Placebo - A7 | Experimental | Drug: BMS-903452, Drug: Placebo(Healthy Subjects) |
| BMS-903452 (0.6 mg) or Placebo - B1 | Experimental | Drug: Placebo, Drug: BMS-903452(Subjects with type 2 Diabetes Mellitus) |
| BMS-903452 (10 mg) or Placebo - B2 | Experimental | Drug: Placebo, Drug: BMS-903452(Subjects with type 2 Diabetes Mellitus) |
| BMS-903452 (120 mg) or Placebo - B3 | Experimental | Drug: Placebo, Drug: BMS-903452(Subjects with type 2 Diabetes Mellitus) |
| BMS-903452 (10 mg) or Placebo - A11 | Experimental | Drug: BMS-903452, Drug: Placebo(Healthy Subjects) |
| BMS-903452 (60 mg) or Placebo - A12 | Experimental | Drug: BMS-903452, Drug: Placebo(Healthy Subjects) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically healthy or Clinical diagnosis of Type 2 diabetes on a stable dose of metformin monotherapy
Key exclusion criteria (4 listed)
- Type 1 Diabetes
- History of significant heart disease
- Prior bariatric surgery
- Women of childbearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-903452Solution, Oral, 0.1 mg, once daily, 1 day | Drug | BMS-903452 (0.1 mg) or Placebo - A1 |
| BMS-903452Solution, Oral, 0.6 mg, once daily, 1 day | Drug | BMS-903452 (0.6 mg) or Placebo - A2 |
| BMS-903452Suspension, Oral, 3.0 mg, once daily, 1 day | Drug | BMS-903452 (3.0 mg) or Placebo - A3 |
| BMS-903452Suspension, Oral, 10 mg, once daily, 1 day | Drug | BMS-903452 (10 mg) or Placebo - A4 |
| BMS-903452Suspension, Oral, 30 mg, once daily, 1 day | Drug | BMS-903452 (30 mg) or Placebo - A5 |
| BMS-903452Suspension, Oral, 60 mg, once daily, 1 day | Drug | BMS-903452 (60 mg) or Placebo - A6 |
| BMS-903452Suspension, Oral, 120 mg, once daily, 1 day | Drug | BMS-903452 (120 mg) or Placebo - A7 |
| PlaceboSolution, Oral, 0 mg, once daily, 1 day | Drug | BMS-903452 (0.1 mg) or Placebo - A1, BMS-903452 (0.6 mg) or Placebo - A2, BMS-903452 (0.6 mg) or Placebo - B1 |
| PlaceboSuspension, Oral, 0 mg, once daily, 1 day | Drug | BMS-903452 (10 mg) or Placebo - A4, BMS-903452 (10 mg) or Placebo - B2, BMS-903452 (120 mg) or Placebo - A7, BMS-903452 (120 mg) or Placebo - B3, BMS-903452 (3.0 mg) or Placebo - A3, BMS-903452 (30 mg) or Placebo - A5, BMS-903452 (60 mg) or Placebo - A6 |
| BMS-903452Suspension using crystalline form, Oral, 10 mg, once daily, 1 day | Drug | BMS-903452 (10 mg) or Placebo - A11 |
| BMS-903452Suspension using crystalline form, Oral, 60 mg, once daily, 1 day | Drug | BMS-903452 (60 mg) or Placebo - A12 |
| PlaceboSuspension using crystalline form, Oral, 0 mg, once daily, 1 day | Drug | BMS-903452 (10 mg) or Placebo - A11, BMS-903452 (60 mg) or Placebo - A12 |
| BMS-903452Solution, Oral, 0.6 mg, once daily, 1 day | Drug | BMS-903452 (0.6 mg) or Placebo - B1 |
| BMS-903452Suspension, Oral, 10 mg, once daily, 1 day | Drug | BMS-903452 (10 mg) or Placebo - B2 |
| BMS-903452Suspension, Oral, 120 mg, once daily, 1 day | Drug | BMS-903452 (120 mg) or Placebo - B3 |
Primary outcome
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Time frame: Within 10 days of study drug administration
10 secondary outcomes
Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism
Time frame: Within 2 days of study drug administration
Effect on electrocardiographic (ECG) parameters
Time frame: Within 10 days of study drug administration
Percent urinary recovery (% UR)
Time frame: Within 10 days of study drug administration
Renal clearance (CLR) from plasma
Time frame: Within 10 days of study drug administration
The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter time to reach maximum observed concentration in plasma (Tmax) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter time Area under the plasma concentration-time curve from time zero extrapolated to infinity AUC(INF) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter Area under the plasma concentration-time curve from time zero to last measurable sampling time AUC (0-T) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter Terminal-phase elimination half-life in plasma (T-Half) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter apparent clearance from plasma after extra-vascular administration (CLT/F) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-903452 in people with Diabetes, run by Bristol-Myers Squibb at 2 sites in United States.
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 4 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 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments (time frame: Within 10 days of study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2012.