Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects

October 12, 2015 updated by: Bristol-Myers Squibb

Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose and Parallel Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-830216 (Prodrug of BMS-819881) in Obese Subjects

The purpose of this study is to evaluate the safety, tolerability and effect on body weight and other obesity-related factors of different doses of BMS-830216, compared to placebo. The study will also determine the amount of BMS-830216 in the blood.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • 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

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obese subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body Mass Index (BMI) of 30 to 40 kg/m², inclusive
  • Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55, inclusive

Exclusion Criteria:

  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
  • Female of childbearing potential
  • Sexually active fertile male not using effective birth control method (for example, condom) if your partners are females of childbearing potential
  • Abnormal blood work results (for example, triglyceride ≥ 400 mg/dL, glucose ≥126 mg/dL and total cholesterol ≥ 300 mg/dL)
  • High blood pressure (≥160/95 mm Hg)
  • Major surgical procedure within 4 weeks prior to randomization
  • Chronic infections (e.g., HIV [human immunodeficiency virus] or Hepatitis C)
  • Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease, or a previous surgery for weight loss
  • History of gastrointestinal disease within the past 3 months
  • History of Type I or Type II diabetes in the past 12 months
  • A lifetime history of a suicide attempt or history of any suicidal behavior in the past month
  • Any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator
  • Used grapefruit or grapefruit juice within 1 week prior to randomization
  • Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization
  • Unable to tolerate oral and/or intravenous (IV) medications
  • Unable to tolerate the puncturing of veins for drawing of blood
  • Prior exposure to BMS-830216
  • History of prior weight loss (for example, gastric bypass or gastric banding) or gastrointestinal surgery that could impact the absorption of study drug
  • History of a Major Depressive Disorder within the past 2 years
  • Known allergy or hypersensitivity to any component of the study medication
  • History of any significant drug allergies (such as anaphylaxis or hepatotoxicity)
  • Used any oral, injectable or implantable hormonal contraceptive agents (for example, birth control pills, Depo-Provera, or NuvaRing) within 3 months prior to randomization
  • Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization
  • Used any prescription drugs, over the counter medications and herbal preparations within 1 week prior to randomization
  • Taken St. John's Wort within 1 week prior to randomization
  • Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Panel A
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 30 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 100 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 300 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 600 mg, once daily 28 days
Drug: BMS-830216
Capsules, oral, 1200 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel B
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 30 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 100 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 300 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 600 mg, once daily 28 days
Drug: BMS-830216
Capsules, oral, 1200 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel C
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 30 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 100 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 300 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 600 mg, once daily 28 days
Drug: BMS-830216
Capsules, oral, 1200 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel D
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 30 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 100 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 300 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 600 mg, once daily 28 days
Drug: BMS-830216
Capsules, oral, 1200 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel E
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 30 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 100 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 300 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 600 mg, once daily 28 days
Drug: BMS-830216
Capsules, oral, 1200 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel F
Low Dose
Drug: BMS-830216
Capsules, Oral, 30 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 100 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 300 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 600 mg, once daily 28 days
Drug: BMS-830216
Capsules, oral, 1200 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel G
High Dose
Drug: BMS-830216
Capsules, Oral, 30 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, 100 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 300 mg, once daily, 28 days
Drug: BMS-830216
Capsules, oral, 600 mg, once daily 28 days
Drug: BMS-830216
Capsules, oral, 1200 mg, once daily, 28 days
Drug: BMS-830216
Capsules, Oral, to be determined, once daily, 28 days
Placebo Comparator: Panel H
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests
Time Frame: Within 2 weeks after study drug administration
Within 2 weeks after study drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacokinetics: to assess the multiple-dose PK of BMS-830216
Time Frame: Within 2 weeks of study drug administration
Within 2 weeks of study drug administration
Pharmacodynamics: to assess the pharmacodynamic effect of BMS-830216 on body weight and BMI over 4 weeks of therapy
Time Frame: Within 2 weeks of study drug administration
Within 2 weeks of study drug administration

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MB123-002

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.

Clinical Trials on Obesity

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings