Healthy VolunteersPhase 1NCT05852769

A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

A Phase 1 study testing BMS-986196, Caffeine and Montelukast in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.

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

This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants. 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-986196, Caffeine and Montelukast
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 31 May 2023to 24 Aug 2023
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 participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m^2), inclusive, and body weight ≥50.0 kg.

Who cannot join

History of rhabdomyolysis.
History of peptic ulcer disease or significant GI bleeding.
History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).

Trial locations and contacts

1 site in 1 country.

United States1 site

ICON plc
Millcreek, Utah, 84124

Other trials in United States

About this study

Official title: A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.

Conditions: Healthy Volunteers
Being tested: BMS-986196, Caffeine, Montelukast, Flurbiprofen, Omeprazole
Keywords: BMS-986196

What participants receive

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

BMS-986196Drug
Specified dose on specified days
CaffeineDrug
Specified dose on specified days
MontelukastDrug
Specified dose on specified days
FlurbiprofenDrug
Specified dose on specified days
OmeprazoleDrug
Specified dose on specified days
MidazolamDrug
Specified dose on specified days
DigoxinDrug
Specified dose on specified days
PravastatinDrug
Specified dose on specified days

Study groups in NCT05852769
Study group	Role	What they receive
BMS-986196 and/or Cocktail Probe Substrate Drugs	Experimental	Not described Receives: Drug: BMS-986196; Drug: Caffeine; Drug: Montelukast; Drug: Flurbiprofen; Drug: Omeprazole; Drug: Midazolam; Drug: Digoxin; Drug: Pravastatin

What is being measured

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

Maximum observed plasma concentration (Cmax)
Measured: Up to 26 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Measured: Up to 26 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Measured: Up to 26 days

Secondary outcomes (9)

Time of maximum observed serum concentration (Tmax)
Measured: Up to 26 days
Apparent terminal phase half-life (T-Half)
Measured: Up to 26 days
Apparent total body clearance (CLT/F)
Measured: Up to 26 days
Number of participants with adverse events (AEs)
Measured: Up to 52 days
Number of participants with vital sign abnormalities
Measured: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 21 days
Number of participants with physical examination abnormalities
Measured: Up to 28 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 28 days
Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Measured: Up to 28 days

Timeline

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

31 May 202324 Aug 2023

First posted10 May 2023
Study start31 May 2023
Primary completion24 Aug 2023
Study completion24 Aug 2023

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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05852769
Sponsor's protocol ID: IM038-022
Status last verified: Sep 2023
First submitted: 1 May 2023
Last updated: 26 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
ClinicalTrials.gov ID: NCT05852769
Acronym / sponsor ID: IM038-022
Conditions: Healthy Volunteers
Keywords: BMS-986196
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 31 May 2023 (actual)
Primary completion: 24 Aug 2023 (actual)
Study completion: 24 Aug 2023 (actual)
First posted: 10 May 2023 (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 is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BMS-986196 and/or Cocktail Probe Substrate Drugs	Experimental	Drug: BMS-986196, Drug: Caffeine, Drug: Montelukast, Drug: Flurbiprofen, Drug: Omeprazole, Drug: Midazolam, Drug: Digoxin, Drug: Pravastatin

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 participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m^2), inclusive, and body weight ≥50.0 kg.

Key exclusion criteria (3 listed)

History of rhabdomyolysis.
History of peptic ulcer disease or significant GI bleeding.
History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).

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-986196Specified dose on specified days	Drug	BMS-986196 and/or Cocktail Probe Substrate Drugs
CaffeineSpecified dose on specified days	Drug	BMS-986196 and/or Cocktail Probe Substrate Drugs
MontelukastSpecified dose on specified days	Drug	BMS-986196 and/or Cocktail Probe Substrate Drugs
FlurbiprofenSpecified dose on specified days	Drug	BMS-986196 and/or Cocktail Probe Substrate Drugs
OmeprazoleSpecified dose on specified days	Drug	BMS-986196 and/or Cocktail Probe Substrate Drugs
MidazolamSpecified dose on specified days	Drug	BMS-986196 and/or Cocktail Probe Substrate Drugs
DigoxinSpecified dose on specified days	Drug	BMS-986196 and/or Cocktail Probe Substrate Drugs
PravastatinSpecified dose on specified days	Drug	BMS-986196 and/or Cocktail Probe Substrate Drugs

Primary outcome

Maximum observed plasma concentration (Cmax)
Time frame: Up to 26 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 26 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Time frame: Up to 26 days

9 secondary outcomes

Time of maximum observed serum concentration (Tmax)
Time frame: Up to 26 days
Apparent terminal phase half-life (T-Half)
Time frame: Up to 26 days
Apparent total body clearance (CLT/F)
Time frame: Up to 26 days
Number of participants with adverse events (AEs)
Time frame: Up to 52 days
Number of participants with vital sign abnormalities
Time frame: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 21 days
Number of participants with physical examination abnormalities
Time frame: Up to 28 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 28 days
Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Up to 28 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 26 Sep 2023.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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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-986196, Caffeine and Montelukast in people with Healthy Volunteers, 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 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 26 Sep 2023. 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 (Cmax) (time frame: Up to 26 days). The study lists 3 primary outcomes in all. 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 NCT05852769.

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 26 Sep 2023.