Single Dose Study of BMS-820836

January 24, 2011 updated by: Bristol-Myers Squibb

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Depression

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5V 2T3
    - Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
Right-handed, non-ambidextrous subjects for Part 2
Men and women, ages 18 to 55 years, inclusive

Exclusion Criteria:

Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
WOCBP using a prohibited contraceptive method
Women who are pregnant or breastfeeding
Sexually active fertile men not using effective birth control if their partners are WOCBP
Any significant acute or chronic medical illness
Current or recent (within 3 months) gastrointestinal disease
History of cholecystectomy
Any major surgery within 4 weeks of study drug administration
Any gastrointestinal surgery that could impact the absorption of study drug
Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
Blood transfusion within 4 weeks of study drug administration
Inability to tolerate/swallow oral medication
Difficulty with venipuncture and/or poor venous access
Self-reported smokers
Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)
Confirmed resting supine systolic blood pressure > 130 mmHg
Confirmed resting supine diastolic blood pressure > 80 mmHg
Confirmed QT value ≥ 500 msec
Confirmed QTc (Bazett) value ≥ 450 msec
History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
History of peppermint allergies
History of brain conditions (e.g. history of stroke, head trauma, etc.)
History of or current psychiatric conditions
History of claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BMS-820836 (Part 1, Panel 1)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose Drug: Placebo Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 2)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose Drug: Placebo Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 3)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose Drug: Placebo Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 4)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose Drug: Placebo Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 5)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose Drug: Placebo Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 6)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose Drug: Placebo Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 7)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose Drug: Placebo Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 8)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose Drug: Placebo Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 9)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose Drug: Placebo Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 2, Panel A)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 2, Panel B)	Drug: BMS-820836 Oral Solution, Oral, 0.025 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.25 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 0.5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 1 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 2 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 3 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 5 mg, single dose, one dose Drug: BMS-820836 Oral Solution, Oral, 8 mg, single dose, one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the safety and tolerability of BMS-820836 following single-dose administration Time Frame: Within 14 days of first dose	Within 14 days of first dose

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007 Time Frame: Within 7 days of dosing	Within 7 days of dosing
To assess the pharmacodynamics of BMS-820836 Time Frame: Within 48 hours of dosing	Within 48 hours of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CN162-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Single Dose Study of BMS-820836

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Subjects

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Depression

Clinical Trials on BMS-820836

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations