HealthyPhase 1NCT03936374
A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants
A Phase 1 study testing BMS-986205 and omeprazole in people with Healthy, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BMS-986205 and omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2019to 20 Jul 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than or equal to (>=) 80 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2)
- Body mass index (BMI) of 18.0 kilogram per meter square (kg/m^2) to 32.0 kg/m^2
- Women participants must have documented proof that they are not of childbearing potential
Who cannot join
- Women who are of childbearing potential or breastfeeding
- Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years
- Concomitant use of strong inhibitors or strong inducers of CYP3A4
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effect of Coadministration of a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of BMS-986205 in Healthy Subjects
The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.
- Conditions
- Healthy
- Being tested
- BMS-986205, omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986205Drug
Participants will receive BMS-986205 on Days 1 and 15
omeprazoleDrug
Participants will receive omeprazole on Days 10 to 15
| Study group | Role | What they receive |
|---|---|---|
| BMS-986205 + Omeprazole | Experimental | Not described Receives: Drug: BMS-986205; Drug: omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of BMS-986205
Measured: Up to Day 29
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205
Measured: Up to Day 29
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Measured: Up to Day 29
Secondary outcomes (5)
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
Measured: Up to Day 36
Number of Participants with Vital Sign Abnormalities
Measured: Up to Day 29
Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities
Measured: Up to Day 29
Number of Participants with Physical Examination Abnormalities
Measured: Up to Day 29
Number of Participants with Clinical Laboratory Results Abnormalities
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start8 May 2019
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonia Davidson, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936374
- Sponsor's protocol ID
- CA017-089
- Status last verified
- Sep 2019
- First submitted
- 1 May 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Coadministration of a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of BMS-986205 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03936374
- Acronym / sponsor ID
- CA017-089
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 May 2019 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 3 May 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 purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986205 + Omeprazole | Experimental | Drug: BMS-986205, Drug: omeprazole |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Health male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than or equal to (>=) 80 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2)
- Body mass index (BMI) of 18.0 kilogram per meter square (kg/m^2) to 32.0 kg/m^2
- Women participants must have documented proof that they are not of childbearing potential
Key exclusion criteria (4 listed)
- Women who are of childbearing potential or breastfeeding
- Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years
- Concomitant use of strong inhibitors or strong inducers of CYP3A4
- 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
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-986205Participants will receive BMS-986205 on Days 1 and 15 | Drug | BMS-986205 + Omeprazole |
| omeprazoleParticipants will receive omeprazole on Days 10 to 15 | Drug | BMS-986205 + Omeprazole |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of BMS-986205
Time frame: Up to Day 29
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205
Time frame: Up to Day 29
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Time frame: Up to Day 29
5 secondary outcomes
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
Time frame: Up to Day 36
Number of Participants with Vital Sign Abnormalities
Time frame: Up to Day 29
Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 29
Number of Participants with Physical Examination Abnormalities
Time frame: Up to Day 29
Number of Participants with Clinical Laboratory Results Abnormalities
Time frame: Up to Day 29
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 23 Sep 2019.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS clinical trial educational resourceLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Antonia Davidson, MD principal investigator
PPD Development, LP
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-986205 and omeprazole in people with Healthy, 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 4 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 23 Sep 2019. 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) of BMS-986205 (time frame: Up to Day 29). 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?
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 23 Sep 2019.