Healthy VolunteersPhase 1NHVNCT01525823
Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin
A Phase 1 study testing BMS-754807 (IGR-IR/IR Inhibitor) and Metformin in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in Australia.
Trial summary
The purpose of this study is to assess the effects of Metformin administered over two weeks on the peak plasma glucose concentrations following administration of BMS-754807. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-754807 (IGR-IR/IR Inhibitor) and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2012to Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects ages 18 to 55 determined with no clinically significant deviation from normal medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory
- Women who are not of childbearing potential
Who cannot join
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations consistent with a healthy volunteer target population
- History of clinically relevant hypoglycemic events
- History of clinically relevant hyperglycemic events
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects
The purpose of this study is to assess the effects of Metformin administered over two weeks on the peak plasma glucose concentrations following administration of BMS-754807.
Read the detailed description
Primary Purpose: Other - Protocol designed to evaluate pharmacodynamics following administration of two compounds
- Conditions
- Healthy Volunteers
- Being tested
- BMS-754807 (IGR-IR/IR Inhibitor), Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-754807 (IGR-IR/IR Inhibitor)Drug
Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17
MetforminDrug
Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily
| Study group | Role | What they receive |
|---|---|---|
| BMS-754807 + Metformin | Experimental | Not described Receives: Drug: BMS-754807 (IGR-IR/IR Inhibitor); Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration
Measured: On Day 3 and Day 17
Secondary outcomes (9)
Safety endpoints: AEs and marked clinical laboratory abnormalities
Incidence of adverse events (AEs), AEs leading to discontinuation, serious adverse events (SAEs), and deaths occurring up to 30 days after the last dose of study medication and marked abnormalities of laboratory values
Measured: Day -21 to Day 47
Maximum observed plasma concentration (Cmax) of BMS-754807 and M5
Measured: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Time of maximum observed plasma concentration (Tmax) of BMS-754807 and M5
Measured: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-754807 and M5
Measured: 12 timepoints over 72 hours for the Day 5 dose
Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-754807 and M5
Measured: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration [AUC(0-T)] of BMS-754807 and M5
Measured: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Plasma half-life (T-HALF) of BMS-754807 and M5
Measured: 12 timepoints over 72 hours for the Day 5 dose
Accumulation index; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (AI) of BMS-754807 and M5
Measured: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Mean levels of plasma glucose, serum insulin and c-peptide
Measured: Day 3, Day 5 and Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT01525823
- Sponsor's protocol ID
- CA191-015
- Acronym
- NHV
- Status last verified
- Jun 2012
- First submitted
- 18 Jan 2012
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects
- ClinicalTrials.gov ID
- NCT01525823
- Acronym / sponsor ID
- NHV / CA191-015
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Feb 2012 (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 assess the effects of Metformin administered over two weeks on the peak plasma glucose concentrations following administration of BMS-754807.
Detailed description
Primary Purpose: Other - Protocol designed to evaluate pharmacodynamics following administration of two compounds
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-754807 + Metformin | Experimental | Drug: BMS-754807 (IGR-IR/IR Inhibitor), Drug: Metformin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects ages 18 to 55 determined with no clinically significant deviation from normal medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory
- Women who are not of childbearing potential
Key exclusion criteria (3 listed)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations consistent with a healthy volunteer target population
- History of clinically relevant hypoglycemic events
- History of clinically relevant hyperglycemic events
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-754807 (IGR-IR/IR Inhibitor)Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17 | Drug | BMS-754807 + Metformin |
| MetforminTablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily | Drug | BMS-754807 + Metformin |
Primary outcome
Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration
Time frame: On Day 3 and Day 17
9 secondary outcomes
Safety endpoints: AEs and marked clinical laboratory abnormalities
Time frame: Day -21 to Day 47
Maximum observed plasma concentration (Cmax) of BMS-754807 and M5
Time frame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Time of maximum observed plasma concentration (Tmax) of BMS-754807 and M5
Time frame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-754807 and M5
Time frame: 12 timepoints over 72 hours for the Day 5 dose
Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-754807 and M5
Time frame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration [AUC(0-T)] of BMS-754807 and M5
Time frame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Plasma half-life (T-HALF) of BMS-754807 and M5
Time frame: 12 timepoints over 72 hours for the Day 5 dose
Accumulation index; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (AI) of BMS-754807 and M5
Time frame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Mean levels of plasma glucose, serum insulin and c-peptide
Time frame: Day 3, Day 5 and Day 17
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 14 Jun 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
1 site 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-754807 (IGR-IR/IR Inhibitor) and Metformin in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in Australia.
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 2 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 14 Jun 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 Australia. 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?
Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration (time frame: On Day 3 and Day 17). 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 14 Jun 2012; AzTrials last refreshed its copy on 7 Nov 2026.