Japanese Phase 1 Multiple Ascending Dose (MAD) Study
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01396252
First received: July 15, 2011
Last updated: March 28, 2013
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: BMS-820836 Drug: Placebo matching BMS-820836 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
- Multiple-dose pharmacokinetics parameter Concentration at 24 h (C24) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
- Multiple-dose pharmacokinetics parameter Time of maximum observed concentration (Tmax) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Multiple-dose pharmacokinetics parameter Apparent total body clearance (CLT/F) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
- Multiple-dose pharmacokinetics parameter accumulation index (AI) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
- Multiple-dose pharmacokinetics parameter half-life (T-HALF) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
- Multiple-dose pharmacokinetics parameter Molar ratio of metabolite to parent Cmax or AUC(TAU) [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
- ECG parameters (heart rate, PR, QRS, QT, and QTcF intervals) [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: Yes ]
| Enrollment: | 57 |
| Study Start Date: | September 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm1: BMS-820836
Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
|
Drug: BMS-820836
Tablets, Oral, 0.5 mg, Once daily, 14 days
Drug: BMS-820836
Tablets, Oral, 1 mg, Once daily, 14 days
Drug: BMS-820836
Tablets, Oral, 2 mg, Once daily, 14 days
Drug: BMS-820836
Tablets, Oral, (initiated at 1 mg and dose escalated to the target dose of 2 mg), Once daily, 14 days
|
|
Placebo Comparator: Arm 2: Placebo matching BMS-820836
Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
|
Drug: Placebo matching BMS-820836
Tablets, Oral, 0 mg, Once daily, 14 days
|
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01396252 History of Changes |
| Other Study ID Numbers: | CN162-014 |
| Study First Received: | July 15, 2011 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013