Healthy ParticipantsPhase 1NCT04949269
A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants
A Phase 1 study testing Deucravacitinib and Famotidine in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to assess the drug levels of deucravacitinib after oral administration 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 Participants
- What is being tested?
- Deucravacitinib and Famotidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jul 2021to 3 Jan 2022
- 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 participants, as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb).
- Willing and able to consume 4 units of alcohol (Part C only). Only participants with low to moderate alcohol consumption will be enrolled in Part C of this study (ie, consumption of between 1 and 21 units per week for males and between 1 and 14 units per week in females).
Who cannot join
- Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug.
- Any 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.
- Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PPD Development, LP
Austin, Texas, 78744
Quotient Sciences Miami
Miami, Florida, 33126
About this study
Official title: A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Tablet Formulations in Healthy Subjects
The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Deucravacitinib, Famotidine
- Keywords
- Healthy Participants, Deucravacitinib, BMS-986165
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
Also called BMS-986165
Specified dose on specified days
FamotidineDrug
Also called Pepcid
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: Deucravacitinib |
| Part B | Experimental | Not described Receives: Drug: Deucravacitinib |
| Part C | Experimental | Not described Receives: Drug: Deucravacitinib; Drug: Famotidine |
| Part D | Experimental | Not described Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of deucravacitinib
Measured: Up to 7 days
Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib
Measured: Up to 7 days
Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib
Measured: Up to 7 days
Secondary outcomes (13)
Incidence of non-serious Adverse Events (AEs)
Measured: Up to 18 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 30 days post discontinuation of dosing or participant's participation in the study
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Measured: Up to 11 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Measured: Up to 11 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Measured: Up to 11 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 11 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 11 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 11 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 11 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval is the time from the onset of the P wave to the start of the QRS complex
Measured: Up to 11 days
Incidence of clinically significant changes in ECG parameters: QRS
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Measured: Up to 11 days
Incidence of clinically significant changes in ECG parameters: QT interval
The QT interval is the time from the start of the Q wave to the end of the T wave
Measured: Up to 11 days
Incidence of clinically significant changes in ECG parameters: QTcF
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Measured: Up to 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start20 Jul 2021
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT04949269
- Sponsor's protocol ID
- IM011-120
- Status last verified
- Feb 2022
- First submitted
- 30 Jun 2021
- Last updated
- 11 Mar 2022
- 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 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Tablet Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04949269
- Acronym / sponsor ID
- IM011-120
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, Deucravacitinib, BMS-986165
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 2 Jul 2021 (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 drug levels of deucravacitinib after oral administration in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Deucravacitinib |
| Part B | Experimental | Drug: Deucravacitinib |
| Part C | Experimental | Drug: Deucravacitinib, Drug: Famotidine |
| Part D | Experimental | Drug: Deucravacitinib |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb).
- Willing and able to consume 4 units of alcohol (Part C only). Only participants with low to moderate alcohol consumption will be enrolled in Part C of this study (ie, consumption of between 1 and 21 units per week for males and between 1 and 14 units per week in females).
Key exclusion criteria (4 listed)
- Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug.
- Any 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.
- Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.
- Other protocol-defined inclusion/exclusion criteria 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 |
|---|---|---|
| DeucravacitinibAlso: BMS-986165Specified dose on specified days | Drug | Part A, Part B, Part C, Part D |
| FamotidineAlso: PepcidSpecified dose on specified days | Drug | Part C |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of deucravacitinib
Time frame: Up to 7 days
Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib
Time frame: Up to 7 days
Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib
Time frame: Up to 7 days
13 secondary outcomes
Incidence of non-serious Adverse Events (AEs)
Time frame: Up to 18 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 30 days post discontinuation of dosing or participant's participation in the study
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 11 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Time frame: Up to 11 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 11 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 11 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 11 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 11 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 11 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 11 days
Incidence of clinically significant changes in ECG parameters: QRS
Time frame: Up to 11 days
Incidence of clinically significant changes in ECG parameters: QT interval
Time frame: Up to 11 days
Incidence of clinically significant changes in ECG parameters: QTcF
Time frame: Up to 11 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 11 Mar 2022.
- 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.
- Investigator Inquiry FormLink 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deucravacitinib and Famotidine in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 deucravacitinib (time frame: Up to 7 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?
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 11 Mar 2022.