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Completed

NCT Number: NCT01396252

Japanese Phase 1 Multiple Ascending Dose (MAD) Study

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Taito-Ku, Tokyo, 1110052, Japan

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

BMS-820836

Drug

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

Placebo matching BMS-820836

Drug

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

Primary outcomes

  1. 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)

    Time frame: Day 1 through Day 33

Secondary outcomes

  1. Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007

    Time frame: Day1 through Day 33

  2. Multiple-dose pharmacokinetics parameter Concentration at 24 h (C24) of BMS-820836 and BMS-821007

    Time frame: Day1 through Day 33

  3. Multiple-dose pharmacokinetics parameter Time of maximum observed concentration (Tmax) of BMS-820836 and BMS-821007

    Time frame: Day1 through Day 33

  4. Multiple-dose pharmacokinetics parameter Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-820836 and BMS-821007

    Time frame: Day1 through Day 33

  5. Multiple-dose pharmacokinetics parameter Apparent total body clearance (CLT/F) of BMS-820836 and BMS-821007

    Time frame: Day1 through Day 33

  6. Multiple-dose pharmacokinetics parameter accumulation index (AI) of BMS-820836 and BMS-821007

    Time frame: Day1 through Day 33

  7. Multiple-dose pharmacokinetics parameter half-life (T-HALF) of BMS-820836 and BMS-821007

    Time frame: Day1 through Day 33

  8. Multiple-dose pharmacokinetics parameter Molar ratio of metabolite to parent Cmax or AUC(TAU)

    Time frame: Day1 through Day 33

  9. ECG parameters (heart rate, PR, QRS, QT, and QTcF intervals)

    Time frame: Day1 through Day 33

    QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula

  10. Vital sign measures (heart rate and blood pressure) and the orthostatic changes

    Time frame: Day1 through Day 33

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2011
Registry last updated
Jun 10, 2013

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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