Multiple-Ascending Dose Study

NCT ID: NCT00892840

Last Updated: 2011-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Panels 1 to 7 (BMS-820836 or Placebo)

Group Type EXPERIMENTAL

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-820836

Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bristol-Myers Squibb

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-008488-86

Identifier Type: -

Identifier Source: secondary_id

CN162-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevention of Seasonal Affective Disorder
NCT00046241 COMPLETED PHASE3
Seasonal Affective Depression (SAD) Study
NCT00069459 COMPLETED PHASE1
Prevention of Seasonal Affective Disorder
NCT00046449 COMPLETED PHASE3