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NCT Number: NCT07655518

A Positron Emission Tomography Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants

The purpose of this study is to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be healthy male and female (as assigned at birth) who are individuals not of childbearing potential (INOCBP) without clinically significant deviation from normal in medical history, PE, 12-lead ECG, and clinical laboratory assessments.
  • Participants must have a BMI of 18 to 30 kg/m^2, inclusive, and total body weight ≥ 50 kg.

Exclusion criteria

  • Participants must not have presence or history of any clinically relevant abnormality, condition, or disease-CNS, cardiovascular, renal, hepatic, hematologic, GI, endocrine, pulmonary, psychiatric, neurologic (eg, seizure disorder), or immunologic.
  • Participants must not have history of rhabdomyolysis.
  • Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease.
  • Other protocol defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986521

Drug

Specified dose on specified days

Primary outcomes

  1. Percentage occupancy of M4 receptor in the brain

    Time frame: Up to approximately 28 hours after last dose

    Based on PET scans

Secondary outcomes

  1. Number of participants with treatment-emergent AEs (TEAEs)

    Time frame: Up to Day 38

  2. Number of participants with treatment-emergent serious AEs (SAEs)

    Time frame: Up to Day 38

  3. Number of participants with treatment-emergent suicidal ideation and behavior

    Time frame: Up to Day 11

    Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

  4. Maximum Concentration (Cmax) of BMS-986521 in Plasma

    Time frame: Up to Day 11

  5. Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma

    Time frame: Up to Day 11

  6. Time to Cmax (Tmax) of BMS-986521 in Plasma

    Time frame: Up to Day 11

  7. Effective half-life (T-HALFeff) of BMS-986521 in Plasma

    Time frame: Up to Day 11

  8. Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)

    Time frame: Up to Day 11

  9. Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521

    Time frame: Up to Day 11

  10. Maximal effect (Emax)

    Time frame: Up to approximately 28 hours after last dose

    Plasma concentrations of BMS-986521 versus M4 receptor occupancy

  11. Half maximal effective concentration (EC50)

    Time frame: Up to approximately 28 hours after last dose

    Plasma concentrations of BMS-986521 versus M4 receptor occupancy

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Open-label, Positron Emission Tomography (PET) Imaging Study to Evaluate M4 Muscarinic Acetylcholine Receptor Occupancy in the Central Nervous System Using [11C]MK-6884 PET Tracer Before and After Oral Administration of Multiple Doses of BMS-986521 in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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