Healthy ParticipantsPhase 1NCT04209699
A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers
A Phase 1 study testing BMS-986165 and Famotidine in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986165 and Famotidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2019to 11 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
- Male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive
- All female subjects must have a negative serum or urine pregnancy test
Who cannot join
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
- History of administration of live vaccines within 60 days before screening until clinic discharge
- 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
- Other protocol-defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, 84124
About this study
Official title: An Open-label 3×3 Cross-over Study to Compare Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of Single Doses of BMS-986165 in Healthy Volunteers
The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers
- Conditions
- Healthy Participants
- Being tested
- BMS-986165, Famotidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986165Drug
Single dose
FamotidineDrug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: BMS-986165 alone, fasted | Experimental | Not described Receives: Drug: BMS-986165 |
| Treatment B: BMS-986165 alone, fed | Experimental | Not described Receives: Drug: BMS-986165 |
| Treatment C: BMS-986165 with famotidine pretreatment, fasted | Experimental | Not described Receives: Drug: BMS-986165; Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
Measured: Day 1 to Day 13
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Measured: Day 1 to Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for a tablet dosed with high-fat high-calorie meal versus fasted condition
Measured: Day 1 to Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Measured: Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
Measured: Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Measured: Day 1 to Day 13
Secondary outcomes (4)
Incidence of Adverse Events (AEs)
Measured: Up to 39 days
Number of clinically significant changes in vital sign measurements
Measured: Up to 18 days
Number of clinically significant changes in clinical laboratory test results
Measured: Up to 18 days
Number of clinically significant changes in electrocardiogram (ECG) parameters
Measured: Up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start27 Dec 2019
- Primary completion4 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT04209699
- Sponsor's protocol ID
- IM011-119
- Status last verified
- Apr 2020
- First submitted
- 23 Dec 2019
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label 3×3 Cross-over Study to Compare Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of Single Doses of BMS-986165 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04209699
- Acronym / sponsor ID
- IM011-119
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 24 Dec 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.
The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: BMS-986165 alone, fasted | Experimental | Drug: BMS-986165 |
| Treatment B: BMS-986165 alone, fed | Experimental | Drug: BMS-986165 |
| Treatment C: BMS-986165 with famotidine pretreatment, fasted | Experimental | Drug: BMS-986165, Drug: Famotidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
- Male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive
- All female subjects must have a negative serum or urine pregnancy test
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
- History of administration of live vaccines within 60 days before screening until clinic discharge
- 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
- Other protocol-defined inclusion/exclusion criteria could apply
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-986165Single dose | Drug | Treatment A: BMS-986165 alone, fasted, Treatment B: BMS-986165 alone, fed, Treatment C: BMS-986165 with famotidine pretreatment, fasted |
| FamotidineSingle dose | Drug | Treatment C: BMS-986165 with famotidine pretreatment, fasted |
Primary outcome
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
Time frame: Day 1 to Day 13
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Time frame: Day 1 to Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for a tablet dosed with high-fat high-calorie meal versus fasted condition
Time frame: Day 1 to Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Time frame: Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
Time frame: Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Time frame: Day 1 to Day 13
4 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 39 days
Number of clinically significant changes in vital sign measurements
Time frame: Up to 18 days
Number of clinically significant changes in clinical laboratory test results
Time frame: Up to 18 days
Number of clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 18 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 21 Apr 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.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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-986165 and Famotidine in people with 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 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 21 Apr 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 (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition (time frame: Day 1 to Day 13). The study lists 6 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 21 Apr 2020.