Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Pharmacokinetics, BMS-986521, Placebo, Drug-food Interaction, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Elderly, Relative Bioavailability
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.
Interventions
DRUGBMS-985521
Specified dose on specified days.
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests. * Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg. * For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.
Exclusion criteria
* Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant. * Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome. * Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy). * Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access. * Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to approximately Day 14 |
| Number of participants with treatment-emergent adverse events (AEs) | Up to approximately Day 40 |
| Number of participants with treatment-emergent serious adverse events (SAEs) | Up to approximately Day 40 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma | Up to approximately Day 14 | — |
| Elimination Half-Life (T-HALF) of BMS-986521 in Plasma | Up to approximately Day 14 | — |
| Maximum Concentration (Cmax) of BMS-986521 in Plasma | Up to approximately Day 14 | — |
| Time to Cmax (Tmax) of BMS-986521 in Plasma | Up to approximately Day 14 | — |
| Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F) | Up to approximately Day 14 | — |
| Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521 | Up to approximately Day 14 | — |
| Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521 | Up to approximately Day 14 | — |
| Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma | Up to approximately Day 14 | — |
| Geometric Mean Cmax BMS-986521 under fed and fasted conditions | Up to approximately Day 11 | Cohort 3 |
| Geometric Mean AUC(0-T) BMS-986521 under fed and fasted conditions | Up to approximately Day 11 | Cohort 3 |
| Geometric Mean AUC(INF) BMS-986521 under fed and fasted conditions | Up to approximately Day 11 | Cohort 3 |
| Geometric mean ratios of Cmax for BMS-986521 oral tablet vs solution | Up to approximately Day 11 | Part C |
| Geometric mean ratios of AUC(0-T) for BMS-986521 oral tablet vs solution | Up to approximately Day 11 | Part C |
| Geometric mean ratios of AUC(INF) for BMS-986521 oral tablet vs solution | Up to approximately Day 11 | Part C |
| Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521 | Up to approximately Day 14 | — |
| Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma | Up to approximately Day 14 | — |
| Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma | Up to approximately Day 14 | — |
Countries
United States
Contacts
Primary ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Backup ContactFirst line of the email MUST contain the NCT# and Site #.
Outcome results
None listed