Japanese Bridging Study Conducted in the United States

July 17, 2013 updated by: Bristol-Myers Squibb

A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.

Study Overview

Status

Status

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Withdrawn

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

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 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
    • California
      • Cypress, California, United States, 90630
        • 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

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

20 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female subjects aged 20 to 49 years, with BMI of 18-30 kg/m2
  • First generation Japanese. Subject born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry

Exclusion Criteria:

  • Any significant acute or chronic medical illness.
  • Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
  • Gastrointestinal disease that may impact the absorption of study drug or that required treatment with a protocon inhibitor, antacid or H2 blocker.
  • History of eczema, psoriasis, or any intermittent or active dermatitis.
  • Positive for HIV or HCV

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Experimental: BMS-791325 - Part A, Dose 1
Drug: BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
Drug: BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Drug: Placebo
Capsules, Oral, Single Dose, One day
Drug: Placebo
Capsules, Oral, Every 12 hours, 14 days
Drug: Placebo
Capsules, Oral, Once Daily, 14 days
Drug: Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days
Experimental: BMS-791325 - Part A, Dose 2
Drug: BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
Drug: BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Drug: Placebo
Capsules, Oral, Single Dose, One day
Drug: Placebo
Capsules, Oral, Every 12 hours, 14 days
Drug: Placebo
Capsules, Oral, Once Daily, 14 days
Drug: Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days
Experimental: BMS-791325 - Part A, Dose 3
Drug: BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
Drug: BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Drug: Placebo
Capsules, Oral, Single Dose, One day
Drug: Placebo
Capsules, Oral, Every 12 hours, 14 days
Drug: Placebo
Capsules, Oral, Once Daily, 14 days
Drug: Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days
Experimental: BMS-791325 - Part B, Dose 1
Drug: BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
Drug: BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Drug: Placebo
Capsules, Oral, Single Dose, One day
Drug: Placebo
Capsules, Oral, Every 12 hours, 14 days
Drug: Placebo
Capsules, Oral, Once Daily, 14 days
Drug: Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days
Experimental: BMS-791325 - Part B, Dose 2
Drug: BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
Drug: BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Drug: Placebo
Capsules, Oral, Single Dose, One day
Drug: Placebo
Capsules, Oral, Every 12 hours, 14 days
Drug: Placebo
Capsules, Oral, Once Daily, 14 days
Drug: Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days
Experimental: BMS-791325 - Part B, Dose 3
Drug: BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
Drug: BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Drug: Placebo
Capsules, Oral, Single Dose, One day
Drug: Placebo
Capsules, Oral, Every 12 hours, 14 days
Drug: Placebo
Capsules, Oral, Once Daily, 14 days
Drug: Placebo
Capsules, Oral, Every 12 hours or once daily, 14 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 (adverse events, physical examinations, clinical labs, ECGs, vital signs)
Time Frame: From time of dose to up to 14 days after last dose
From time of dose to up to 14 days after last dose

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
To measure concentration of study drug following single and multiple doses
Time Frame: Within 48 or 72 hours postdose
Within 48 or 72 hours postdose

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
October 1, 2014

Primary Completion (Anticipated)

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.
February 1, 2015

Study Completion (Anticipated)

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.
February 1, 2015

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).
July 27, 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.
July 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.
July 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.
July 18, 2013

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.
July 17, 2013

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.
July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • AI443-011

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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