Multiple-Ascending Dose Study | NCT00892840

Studies
Multiple-Ascending Dose Study

NCT00892840

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Feb 11, 2011Estimated

Enrollment

57Actual

Phase

Phase 1

Conditions

Depression

Interventions

BMS-820836
Placebo

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-008488-86

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

May 2, 2009

First Submission Date that Met QC Criteria

May 4, 2009

First Posted Date

May 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2011

Last Update Posted Date

Feb 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Panels 1 to 7 (BMS-820836 or Placebo)	Experimental		Drug: BMS-820836 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-820836	Drug	Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days	Panels 1 to 7 (BMS-820836 or Placebo)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety and tolerability of BMS-820836 following multiple-dose administration		Within 27 days (+/- 2 days) of first dose

Secondary Outcomes

Measure	Description	Time Frame
To assess the pharmacodynamics of BMS-820836		Within 27 days of first dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Panels 1-6: Healthy Male Subjects
Panel 7: Females
Ages 21 to 55, inclusive
Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive
Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

Any major surgery within 4 weeks of study drug administration
History of cholecystectomy
History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)
Confirmed QTc (Fridericia) value ≥ 450 msec
Confirmed QT ≥ 500 msec
Confirmed PR ≥ 210 msec
Confirmed QRS ≥ 120 msec
Confirmed resting supine systolic blood pressure > 140 mmHg
Confirmed resting supine diastolic blood pressure > 90 mmHg
Confirmed resting heart rate < 45 bpm or > 100 bpm
Orthostatic vital sign changes (ie., a decrease in systolic blood pressure from supine to standing > 40 mmHg and an increase in heart rate from supine to standing > 20 bpm) or symptoms of orthostasis
History of peppermint allergies
Exposure to any investigational drug or placebo within 12 weeks of study drug administration

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Uppsala		751 23	Sweden

ID	Term
D003863	Depression

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
C000594001	6-(2-methyl-4-(2-naphthyl)-1,2,3,4-tetrahydroisoquinolin-7-yl)pyridazin-3-amine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided