Japanese Phase 1 Multiple Ascending Dose (MAD) Study

Randomized, Placebo-Controlled, Double-Blind, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Japanese Subjects and Japanese Patients With Depression

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221590

Enrollment

Registered

2011-09-16

Start date

2011-09-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

investigational material(s) Generic name etc : TRUI(BMS-820836) INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy Japanese subjects and Japanese patients with depression

Exclusion criteria

Exclusion criteria: Any significant acute or chronic medical illness Non-compliance, or overall not suitable as determined by the investigator History of, or current clinically significant psychiatric disorders or illnesses, substance abuse or dependence

Design outcomes

Primary

Measure	Time frame
Safety and tolerability based on medical review of adverse events & results of vital sign measurements, electrocardiogram (ECGs), physical examinations, clinical laboratory test	—

Secondary

Measure	Time frame
Multiple-dose pharmacokinetics parameters of BMS-820836 and BMS-821007 ECG parameters Vital sign measures	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026