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Recruiting NCT07283263

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-985521, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First-in-Human Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered BMS-986521 in Healthy Adult Participants

Overview

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

  • Drug BMS-985521
    Specified dose on specified days.
  • Other Placebo
    Specified dose on specified days

Primary outcome measures

  • Number of participants with treatment-emergent adverse events (AEs) [Time frame: Up to approximately Day 40]
  • Number of participants with treatment-emergent serious adverse events (SAEs) [Time frame: Up to approximately Day 40]
  • Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Up to approximately Day 14]
Secondary outcome measures (12)
  • Maximum Concentration (Cmax) of BMS-986521 in Plasma [Time frame: Up to approximately Day 14]
  • Time to Cmax (Tmax) of BMS-986521 in Plasma [Time frame: 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 [Time frame: Up to approximately Day 14]
  • Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma [Time frame: Up to approximately Day 14]
  • Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma [Time frame: Up to approximately Day 14]
  • Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma [Time frame: Up to approximately Day 14]
  • Elimination Half-Life (T-HALF) of BMS-986521 in Plasma [Time frame: Up to approximately Day 14]
  • Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F) [Time frame: Up to approximately Day 14]
  • Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521 [Time frame: Up to approximately Day 14]
  • Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521 [Time frame: Up to approximately Day 14]
  • Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521 [Time frame: Up to approximately Day 14]
  • Geometric Mean Cmax BMS-986521 under fed and fasted conditions [Time frame: Up to approximately Day 11]

Eligibility criteria

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/exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • CenExel ACT (Formerly Anaheim Clinical Trials; LLC) — Anaheim

Identifiers

NCT: NCT07283263 · CN014-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗