Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female participants without, in the opinion of the investigator, clinically significant deviation from normal in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations. * Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg (110 lb), at screening. Given participants are postpartum, BMI accommodation up to 35.0 kg/m2 may be expected. * Has well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study. * Is willing to exclusively pump breast milk for the 72-hour post dose period of milk collection during CRU confinement, and not to breastfeed or provide milk to infant until after CRU discharge (72 hours post dose).
Exclusion criteria
* Presence or history of any clinically relevant abnormality, condition, or disease (such as liver disease or abnormal liver function tests, or cardiovascular or pulmonary diseases) that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or elimination of the study intervention, that would prevent the participant from participating in the study, or which places the participant at unacceptable risk if she were to participate in the study. * Current or recent (within 3 months of study intervention administration) clinically significant gastrointestinal disease that, in the opinion of the investigator, could impact upon the absorption of study intervention. * Presence or history of mastitis, breast surgery or trauma, or other breast conditions, which are considered clinically significant by the investigator and/or, in the investigator's opinion, may significantly impact breastfeeding or collection of milk from one or both breasts. * History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease, except for isolated gallbladder issues, which are not by themselves exclusionary. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk | First dose day 1 to day 4 up to 72 hours | Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk. |
| Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk | First dose day 1 to day 4 up to 72 hours | Tmax is defined as the time taken to reach the maximum observed concentration (Cmax) of BMS-986165 and BMT-153261 in breast milk. |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk | First dose day 1 up to 24 hours post dose | 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. |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk | 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 breast milk. |
| Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk | First dose day 1 to day 4 up to 72 hours | Cavg defined as the average concentration of BMS-986165 and BMT-153261 in breast milk. |
| Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk | From first dose day 1 up to 24 hours post dose | AR (24) defined as the amount recovered within 24 hours of dosing of BMS-986165 and BMT-153261 in breast milk. |
| Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk | First dose day 1 to day 4 up to 72 hours | AR defined as the total amount recovered of BMS-986165 and BMT-153261 in breast milk. |
| Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261 | First dose day 1 to day 4 up to 72 hours | M/P defined as milk-plasma ratio of BMS-986165 and BMT-153261. |
| Average Estimated Daily Infant Dose | First dose day 1 to day 4 up to 72 hours | 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. |
| Average Relative Infant Dose | First dose day 1 to day 4 up to 72 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma | First dose day 1 to day 4 up to 72 hours | Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in plasma. |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma | 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. |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma | First dose day 1 up to 24 hours post dose | 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. |
| 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 | First dose day 1 to day 4 up to 72 hours | 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. |
| Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma | First dose day 1 to day 4 up to 72 hours | Tmax is defined as the time taken to reach the maximum observed plasma concentration (Cmax) of BMS-986165 and BMT-153261 in plasma. |
| Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma | First dose day 1 to day 4 up to 72 hours | Cavg defined as the average plasma concentration of BMS-986165 and BMT-153261 in plasma. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From the dose of study medication through 30 days (assessed for up to 30 days) | 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. |
| Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | From the dose of study medication through 30 days (assessed for up to 30 days) | Blood samples were collected to assess the abnormalities in laboratory parameters. |
| Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | From the dose of study medication through 30 days (assessed for up to 30 days) | 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. |
| Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs) | From the dose of study medication through 30 days (assessed for up to 30 days) | 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. |
| Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs) | From the dose of study medication through 30 days (assessed for up to 30 days) | 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. |
Countries
United States
Participant flow
Recruitment details
All participants received study treatment at one site in the United States of America.
Pre-assignment details
Total 8 participants received study medication.
Participants by arm
| Arm | Count |
|---|---|
| Deucravacitinib 9 mg Participants received Deucravacitinib at a dose of 9 mg once daily | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Deucravacitinib 9 mg |
|---|---|
| Age, Continuous | 30.5 Years STANDARD_DEVIATION 6.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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.
Time frame: From first dose day 1 up to 24 hours post dose
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk | BMS-986165 | 0.05021 mg | Geometric Coefficient of Variation 102.8 |
| Deucravacitinib 9 mg | Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk | BMT-153261 | 0.03393 mg | Geometric Coefficient of Variation 107.1 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk | BMS-986165 | 1876 h*ng/mL | Geometric Coefficient of Variation 57.9 |
| Deucravacitinib 9 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk | BMT-153261 | 1767 h*ng/mL | Geometric Coefficient of Variation 61.6 |
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.
Time frame: First dose day 1 up to 24 hours post dose
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk | BMS-986165 | 1656 h*ng/mL | Geometric Coefficient of Variation 54.5 |
| Deucravacitinib 9 mg | Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk | BMT-153261 | 1289 h*ng/mL | Geometric Coefficient of Variation 58.7 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk | BMS-986165 | 78.18 ng/mL | Geometric Coefficient of Variation 57.9 |
| Deucravacitinib 9 mg | Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk | BMT-153261 | 73.61 ng/mL | Geometric Coefficient of Variation 61.6 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Deucravacitinib 9 mg | Average Estimated Daily Infant Dose | 0.01586 mg/kg/day | Geometric Coefficient of Variation 58.8 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Deucravacitinib 9 mg | Average Relative Infant Dose | 12.11 Percentage | Geometric Coefficient of Variation 53.6 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk | BMS-986165 | 211.0 ng/mL | Geometric Coefficient of Variation 59.5 |
| Deucravacitinib 9 mg | Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk | BMT-153261 | 74.09 ng/mL | Geometric Coefficient of Variation 55.7 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261 | BMS-986165 | 3.241 Ratio | Geometric Coefficient of Variation 50.9 |
| Deucravacitinib 9 mg | Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261 | BMT-153261 | 15.76 Ratio | Geometric Coefficient of Variation 57.7 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Deucravacitinib 9 mg | Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk | BMS-986165 | 1.00 Hour |
| Deucravacitinib 9 mg | Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk | BMT-153261 | 6.00 Hour |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk | BMS-986165 | 0.05395 mg | Geometric Coefficient of Variation 106 |
| Deucravacitinib 9 mg | Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk | BMT-153261 | 0.04230 mg | Geometric Coefficient of Variation 116.8 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma | BMS-986165 | 587.2 h*ng/mL | Geometric Coefficient of Variation 26.6 |
| Deucravacitinib 9 mg | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma | BMT-153261 | 128.3 h*ng/mL | Geometric Coefficient of Variation 36.6 |
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.
Time frame: First dose day 1 up to 24 hours post dose
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma | BMS-986165 | 511.0 h*ng/mL | Geometric Coefficient of Variation 24.4 |
| Deucravacitinib 9 mg | Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma | BMT-153261 | 81.79 h*ng/mL | Geometric Coefficient of Variation 39.6 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | 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 | BMS-986165 | 575.1 h*ng/mL | Geometric Coefficient of Variation 26.9 |
| Deucravacitinib 9 mg | 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 | BMT-153261 | 104.5 h*ng/mL | Geometric Coefficient of Variation 52.4 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma | BMS-986165 | 24.47 ng/mL | Geometric Coefficient of Variation 26.6 |
| Deucravacitinib 9 mg | Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma | BMT-153261 | 5.346 ng/mL | Geometric Coefficient of Variation 36.6 |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Deucravacitinib 9 mg | Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma | BMS-986165 | 62.56 ng/mL | Geometric Coefficient of Variation 24.5 |
| Deucravacitinib 9 mg | Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma | BMT-153261 | 4.797 ng/mL | Geometric Coefficient of Variation 36.9 |
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.
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)
Population: All Treated Participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib 9 mg | Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
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.
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)
Population: All Treated Participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib 9 mg | Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
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.
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)
Population: All Treated Participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib 9 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
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.
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)
Population: All Treated Participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib 9 mg | Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
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.
Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)
Population: All Treated Participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deucravacitinib 9 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
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.
Time frame: First dose day 1 to day 4 up to 72 hours
Population: All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Deucravacitinib 9 mg | Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma | BMS-986165 | 2.00 Hour |
| Deucravacitinib 9 mg | Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma | BMT-153261 | 6.00 Hour |