Healthy Participants
Conditions
Keywords
Bioequivalence, Food Effect, pH Effect, Healthy Volunteers, Deucravacitinib
Brief summary
The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
DRUGFamotidine
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator. * Participants must be willing and able to complete all study-specific procedures and visits. * Participants must have a body mass index of 18.0 kg/m2 through 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb).
Exclusion criteria
* Participants must not have any significant acute or chronic medical illness that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of/or acute liver disease in the opinion of the Investigator. * Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the population reference ranges in the opinion of the investigator. * Participants must not have any history of severe reaction to a drug (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous), or adverse or allergic/hypersensitivity reaction to multiple drugs. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to day 20 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to day 20 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to day 20 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | Up to day 44 | — |
| Incidence of serious adverse events (SAEs) | Up to day 44 | — |
| Number of participants with physical examination abnormalities | Up to day 21 | A physical examination includes the assessment of the following: head, eyes, ears, nose, and throat (HEENT), cardiovascular (including peripheral vascular), lungs, abdomen, dermatological, and a general neurological examination |
| Incidence of AEs leading to discontinuation | Up to day 44 | — |
| Apparent terminal plasma half-life (T-HALF) | Up to day 20 | — |
| Apparent total body clearance (CLT/F) | Up to day 20 | — |
| Time of maximum observed plasma concentration (Tmax) | Up to day 20 | — |
| Number of participants with a clinically significant change from baseline in vital signs | Up to day 21 | — |
| Number of participants with a change from baseline in 12-lead ECG results | Up to day 21 | — |
Countries
United States
Outcome results
None listed