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The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deucravacitinib Administration | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | Specified dose on specified days |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk | Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk. | First dose day 1 to day 4 up to 72 hours |
| Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk | Tmax is defined as the time taken to reach the maximum observed concentration (Cmax) of BMS-986165 and BMT-153261 in breast milk. | First dose day 1 to day 4 up to 72 hours |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk | AUC(0-24) defined as the area under the concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in breast milk. | First dose day 1 up to 24 hours post dose |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk | AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in breast milk. | First dose day 1 to day 4 up to 72 hours |
| Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk | Cavg defined as the average concentration of BMS-986165 and BMT-153261 in breast milk. | First dose day 1 to day 4 up to 72 hours |
| Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk | AR (24) defined as the amount recovered within 24 hours of dosing of BMS-986165 and BMT-153261 in breast milk. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma | Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in plasma. | First dose day 1 to day 4 up to 72 hours |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Las Vegas | Nevada | 89113-2246 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.
Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
See Plan Description
See Plan Description
Total 8 participants received study medication.
All participants received study treatment at one site in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Deucravacitinib 9 mg | Participants received Deucravacitinib at a dose of 9 mg once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Deucravacitinib 9 mg | Participants received Deucravacitinib at a dose of 9 mg once daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk | Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | First dose day 1 to day 4 up to 72 hours |
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Participants were assessed for All-Cause Mortality, SAEs and Other AEs from the dose of study medication through 30 days (assessed for up to 30 days).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deucravacitinib 9 mg | Participants received Deucravacitinib at a dose of 9 mg once daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2024 | Oct 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| From first dose day 1 up to 24 hours post dose |
| Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk | AR defined as the total amount recovered of BMS-986165 and BMT-153261 in breast milk. | First dose day 1 to day 4 up to 72 hours |
| Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261 | M/P defined as milk-plasma ratio of BMS-986165 and BMT-153261. | First dose day 1 to day 4 up to 72 hours |
| Average Estimated Daily Infant Dose | Average estimated daily infant dose represents the total amount of study medication that an infant is expected to consume each day average from day 1 to day 4, based on available data. | First dose day 1 to day 4 up to 72 hours |
| Average Relative Infant Dose | Average relative infant dose shows the estimated percentage of the mother's weight-adjusted dose of study medication that the infant consumes through breast milk over a 24-hour period. This was averaged from day 1 to day 4 based on available data. | First dose day 1 to day 4 up to 72 hours |
AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in plasma. |
| First dose day 1 to day 4 up to 72 hours |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma | AUC(0-24) defined as the area under the plasma concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in plasma. | First dose day 1 up to 24 hours post dose |
| Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986165 and BMT-153261 in Plasma | AUC(0-T) defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of BMS-986165 and BMT-153261 in plasma. | First dose day 1 to day 4 up to 72 hours |
| Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma | Tmax is defined as the time taken to reach the maximum observed plasma concentration (Cmax) of BMS-986165 and BMT-153261 in plasma. | First dose day 1 to day 4 up to 72 hours |
| Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma | Cavg defined as the average plasma concentration of BMS-986165 and BMT-153261 in plasma. | First dose day 1 to day 4 up to 72 hours |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. | From the dose of study medication through 30 days (assessed for up to 30 days) |
| Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood samples were collected to assess the abnormalities in laboratory parameters. | From the dose of study medication through 30 days (assessed for up to 30 days) |
| Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. | From the dose of study medication through 30 days (assessed for up to 30 days) |
| Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. | From the dose of study medication through 30 days (assessed for up to 30 days) |
| Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. | From the dose of study medication through 30 days (assessed for up to 30 days) |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk | Tmax is defined as the time taken to reach the maximum observed concentration (Cmax) of BMS-986165 and BMT-153261 in breast milk. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Median | Full Range | Hour | First dose day 1 to day 4 up to 72 hours |
|
|
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| Primary | Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk | AUC(0-24) defined as the area under the concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in breast milk. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | First dose day 1 up to 24 hours post dose |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk | AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in breast milk. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | First dose day 1 to day 4 up to 72 hours |
|
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|
| Primary | Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk | Cavg defined as the average concentration of BMS-986165 and BMT-153261 in breast milk. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | First dose day 1 to day 4 up to 72 hours |
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| Primary | Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk | AR (24) defined as the amount recovered within 24 hours of dosing of BMS-986165 and BMT-153261 in breast milk. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | From first dose day 1 up to 24 hours post dose |
|
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| Primary | Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk | AR defined as the total amount recovered of BMS-986165 and BMT-153261 in breast milk. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | First dose day 1 to day 4 up to 72 hours |
|
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| Primary | Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261 | M/P defined as milk-plasma ratio of BMS-986165 and BMT-153261. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | First dose day 1 to day 4 up to 72 hours |
|
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| Primary | Average Estimated Daily Infant Dose | Average estimated daily infant dose represents the total amount of study medication that an infant is expected to consume each day average from day 1 to day 4, based on available data. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/kg/day | First dose day 1 to day 4 up to 72 hours |
|
|
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| Primary | Average Relative Infant Dose | Average relative infant dose shows the estimated percentage of the mother's weight-adjusted dose of study medication that the infant consumes through breast milk over a 24-hour period. This was averaged from day 1 to day 4 based on available data. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | First dose day 1 to day 4 up to 72 hours |
|
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| Secondary | Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma | Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in plasma. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | First dose day 1 to day 4 up to 72 hours |
|
|
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| Secondary | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma | AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in plasma. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | First dose day 1 to day 4 up to 72 hours |
|
|
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| Secondary | Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma | AUC(0-24) defined as the area under the plasma concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in plasma. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | First dose day 1 up to 24 hours post dose |
|
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| Secondary | Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986165 and BMT-153261 in Plasma | AUC(0-T) defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of BMS-986165 and BMT-153261 in plasma. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | First dose day 1 to day 4 up to 72 hours |
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| Secondary | Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma | Tmax is defined as the time taken to reach the maximum observed plasma concentration (Cmax) of BMS-986165 and BMT-153261 in plasma. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Median | Full Range | Hour | First dose day 1 to day 4 up to 72 hours |
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| Secondary | Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma | Cavg defined as the average plasma concentration of BMS-986165 and BMT-153261 in plasma. | All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | First dose day 1 to day 4 up to 72 hours |
|
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. | All Treated Participants. | Posted | Count of Participants | Participants | From the dose of study medication through 30 days (assessed for up to 30 days) |
|
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| Secondary | Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood samples were collected to assess the abnormalities in laboratory parameters. | All Treated Participants. | Posted | Count of Participants | Participants | From the dose of study medication through 30 days (assessed for up to 30 days) |
|
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| Secondary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. | All Treated Participants. | Posted | Count of Participants | Participants | From the dose of study medication through 30 days (assessed for up to 30 days) |
|
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| Secondary | Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. | All Treated Participants. | Posted | Count of Participants | Participants | From the dose of study medication through 30 days (assessed for up to 30 days) |
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| Secondary | Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. | All Treated Participants. | Posted | Count of Participants | Participants | From the dose of study medication through 30 days (assessed for up to 30 days) |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
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