Obese But Otherwise Healthy ParticipantsPhase 1NCT04116632
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
A Phase 1 study testing BMS-963272 in people with Obese But Otherwise Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese But Otherwise Healthy Participants
- What is being tested?
- BMS-963272
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 10 Feb 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be in good general health, in the opinion of the investigator, with no clinically significant deviation from normal in medical history, physical examination findings, ECGs, or laboratory results.
- Participants must have a BMI of 30 kg/m2 to 40 kg/m2 inclusive
- Women (not of childbearing potential) and men aged 18 to 60 years, inclusive
Who cannot join
- Previous participation in the current study
- Inability or unwillingness to comply with protocol-defined restrictions or requirements regarding lifestyle, diet, concomitant medications, or other aspects of the study
- Inability to tolerate the oLTT meal or to comply with oLTT testing conditions
- Inability to tolerate oral medication
- Inability to tolerate venipuncture and/or inadequate venous access
- Women who are breastfeeding
Show all 14Show fewer
- Medical Conditions
- History of lactose intolerance
- Any significant (in the opinion of the investigator) acute or chronic illness
- Type 1 or 2 diabetes
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- Previous/Concomitant Therapy
- Previous exposure to BMS-963272
- Other protocol-defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.
- Conditions
- Obese But Otherwise Healthy Participants
- Being tested
- BMS-963272, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-963272Drug
Single dose with varying frequency among groups
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-963272 or Placebo once daily (QD) | Experimental | Not described Receives: Drug: BMS-963272; Drug: Placebo |
| BMS-963272 or Placebo every 12 hours (Q12H) | Experimental | Not described Receives: Drug: BMS-963272; Drug: Placebo |
| BMS-963272 or Placebo every 8 hours (Q8H) | Experimental | Not described Receives: Drug: BMS-963272; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration of BMS-963272 (Cmax)
Measured: Day 1, Day 14
Time of maximum observed concentration of BMS-963272 (Tmax)
Measured: Day 1, Day 14
Area under the concentration-time curve in one dosing interval (AUC(TAU))
Measured: Day 1, Day 14
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Measured: Day 14
Apparent total clearance of the drug from plasma after oral administration (CLss/F)
Measured: Day 14
Apparent volume of distribution at steady state (Vss/F)
Measured: Day 14
Average concentration at steady state (Cavg,ss)
Measured: Day 14
Half-life (T-HALF)
Measured: Day 14
Accumulation index (AI)
Measured: Day 14
Rate elimination constant (kel) of BMS-963272
Measured: Day 14
Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT)
Measured: Day 7, Day 15
Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT
Measured: Day 7, Day 15
Secondary outcomes (3)
Incidence of Adverse Events (AEs)
Measured: Up to 55 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 55 days
Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests
Measured: Up to 55 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start30 Sep 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese But Otherwise Healthy ParticipantsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 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
- NCT04116632
- Sponsor's protocol ID
- MB006-017
- Status last verified
- May 2020
- First submitted
- 3 Oct 2019
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults
- ClinicalTrials.gov ID
- NCT04116632
- Acronym / sponsor ID
- MB006-017
- Conditions
- Obese But Otherwise Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 4 Oct 2019 (actual)
- 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.
This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMS-963272 or Placebo once daily (QD) | Experimental | Drug: BMS-963272, Drug: Placebo |
| BMS-963272 or Placebo every 12 hours (Q12H) | Experimental | Drug: BMS-963272, Drug: Placebo |
| BMS-963272 or Placebo every 8 hours (Q8H) | Experimental | Drug: BMS-963272, Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be in good general health, in the opinion of the investigator, with no clinically significant deviation from normal in medical history, physical examination findings, ECGs, or laboratory results.
- Participants must have a BMI of 30 kg/m2 to 40 kg/m2 inclusive
- Women (not of childbearing potential) and men aged 18 to 60 years, inclusive
Key exclusion criteria (14 listed)
- Previous participation in the current study
- Inability or unwillingness to comply with protocol-defined restrictions or requirements regarding lifestyle, diet, concomitant medications, or other aspects of the study
- Inability to tolerate the oLTT meal or to comply with oLTT testing conditions
- Inability to tolerate oral medication
- Inability to tolerate venipuncture and/or inadequate venous access
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-963272Single dose with varying frequency among groups | Drug | BMS-963272 or Placebo every 12 hours (Q12H), BMS-963272 or Placebo every 8 hours (Q8H), BMS-963272 or Placebo once daily (QD) |
| PlaceboSpecified dose on specified days | Drug | BMS-963272 or Placebo every 12 hours (Q12H), BMS-963272 or Placebo every 8 hours (Q8H), BMS-963272 or Placebo once daily (QD) |
Primary outcome
Maximum observed plasma concentration of BMS-963272 (Cmax)
Time frame: Day 1, Day 14
Time of maximum observed concentration of BMS-963272 (Tmax)
Time frame: Day 1, Day 14
Area under the concentration-time curve in one dosing interval (AUC(TAU))
Time frame: Day 1, Day 14
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Time frame: Day 14
Apparent total clearance of the drug from plasma after oral administration (CLss/F)
Time frame: Day 14
Apparent volume of distribution at steady state (Vss/F)
Time frame: Day 14
Average concentration at steady state (Cavg,ss)
Time frame: Day 14
Half-life (T-HALF)
Time frame: Day 14
Accumulation index (AI)
Time frame: Day 14
Rate elimination constant (kel) of BMS-963272
Time frame: Day 14
Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT)
Time frame: Day 7, Day 15
Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT
Time frame: Day 7, Day 15
3 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 55 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 55 days
Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests
Time frame: Up to 55 days
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 May 2020.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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-963272 in people with Obese But Otherwise Healthy Participants, run by Bristol-Myers Squibb at 1 site 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 3 inclusion and 14 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 May 2020. 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 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?
Maximum observed plasma concentration of BMS-963272 (Cmax) (time frame: Day 1, Day 14). The study lists 12 primary outcomes in all. 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 May 2020.