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

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01396252

Enrollment

Registered

2011-07-18

Start date

2011-09-30

Completion date

2012-05-31

Last updated

2013-06-10

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

Conditions

Depression

Brief summary

The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.

Interventions

DRUGBMS-820836

Tablets, Oral, 0.5 mg, Once daily, 14 days

DRUGPlacebo matching BMS-820836

Tablets, Oral, 0 mg, Once daily, 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Japanese subjects and Japanese patients with depression (Hamilton Rating Scale for Depression (HAM-D) ≥ 14), ages 20 to 55 years.

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, suicidality evaluation & Montgomery Asberg Depression Rating Scale (MADRS)	Day 1 through Day 33

Secondary

Measure	Time frame	Description
Multiple-dose pharmacokinetics parameter Concentration at 24 h (C24) of BMS-820836 and BMS-821007	Day1 through Day 33	—
Multiple-dose pharmacokinetics parameter Time of maximum observed concentration (Tmax) of BMS-820836 and BMS-821007	Day1 through Day 33	—
Multiple-dose pharmacokinetics parameter Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-820836 and BMS-821007	Day1 through Day 33	—
Multiple-dose pharmacokinetics parameter Apparent total body clearance (CLT/F) of BMS-820836 and BMS-821007	Day1 through Day 33	—
Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007	Day1 through Day 33	—
Multiple-dose pharmacokinetics parameter half-life (T-HALF) of BMS-820836 and BMS-821007	Day1 through Day 33	—
Multiple-dose pharmacokinetics parameter Molar ratio of metabolite to parent Cmax or AUC(TAU)	Day1 through Day 33	—
ECG parameters (heart rate, PR, QRS, QT, and QTcF intervals)	Day1 through Day 33	QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula
Vital sign measures (heart rate and blood pressure) and the orthostatic changes	Day1 through Day 33	—
Multiple-dose pharmacokinetics parameter accumulation index (AI) of BMS-820836 and BMS-821007	Day1 through Day 33	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026