Study of [3H] BMS747158 in Healthy Male Subjects (PPA103)

November 6, 2020 updated by: Lantheus Medical Imaging

Pharmacokinetics, Metabolism and Elimination of Tritiated [3H] BMS747158 in Healthy Male Subjects

The purpose of this clinical study is to assess the safety, extent and route of [3H] BMS747158 radioactivity eliminated (mass balance) in urine and feces of healthy male subjects. The safety of [3H] BMS747158 administration will also be assessed, as well as pharmacokinetics of [3H] BMS747158 and metabolite identification.

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.

Detailed Description

This Phase I, nonrandomized, open-label study will enroll up to seven healthy male subjects who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 100 (±20) μCi of [3H] BMS747158. Subjects will undergo blood, urine, and fecal collections to evaluate [3H] activity for a minimum of 7 days post-dose. Safety will be assessed by monitoring of adverse events (AEs), vital signs, physical examinations, clinical laboratory tests, and electrocardiograms (ECGs).This Phase I, nonrandomized, open-label study will enroll up to seven healthy male subjects who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 100 (±20) μCi of [3H] BMS747158. Subjects will undergo blood, urine, and fecal collections to evaluate [3H] activity for a minimum of 7 days post-dose. Safety will be assessed by monitoring of adverse events (AEs), vital signs, physical examinations, clinical laboratory tests, and electrocardiograms (ECGs).

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.
7

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Covance Clinical Laboratory Unit

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 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Provide written signed informed consent prior to any study procedures
  2. Be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory tests
  3. Have a Body Mass Index (BMI) of 18 to 30 kg/m2
  4. Be male, age 18 to 45 years

  5. Be sterile or agree to use from admission until discharge one of the following approved methods of contraception:

    • a male condom with spermicide
    • a sterile sexual partner
    • use by female sexual partner of an intrauterine device (IUD) with spermicide *a female condom with spermicide contraceptive sponge with spermicide
    • an intravaginal system [e.g., NuvaRing®]
    • a diaphragm with spermicide
    • a cervical cap with spermicide, or
    • oral, implantable, transdermal, or injectable contraceptives
  6. Must be able to communicate effectively with study personnel

Exclusion Criteria:

  1. Any significant active or chronic medical illness or acute significant trauma
  2. History of any condition that may disrupt and/or increase permeability of the blood-brain barrier or diabetes
  3. History of any neurological disease.
  4. History of concussion or meningitis within the past 6 months
  5. History of sleep disorders, including snoring with sleep apnea and narcolepsy
  6. History of anxiety disorder
  7. Current or recent GI disease
  8. Major surgery within 4 weeks
  9. GI surgery that could impact upon the re-absorption of study drug
  10. History of chronic constipation
  11. History of asthma as deemed clinically significant by the Investigator or designee
  12. History of recent (within 2 weeks of enrollment) infection (e.g., upper respiratory tract infection, urinary tract infection)
  13. Known and confirmed drug allergies or hypersensitivities
  14. Donation of blood and/or plasma to a blood bank or in a clinical study (except as required for screening) within four weeks of enrollment
  15. Blood transfusion within four weeks of enrollment
  16. Inability to tolerate intravenous medication or unlikely to obtain and/or tolerate venous access
  17. Past (6 months) or present history of drug or alcohol abuse
  18. Screening or pre-dose ECG interval abnormalities or organ dysfunction.
  19. Positive urine screen for drugs of abuse either at screening or before dosing
  20. Positive blood screen for hepatitis B surface antigen, hepatitis C antibody, or HIV
  21. Exposure to any investigational drug, device, or placebo within four weeks of enrollment
  22. Use of any prescription drugs within 4 weeks of enrollment
  23. Use of any other drugs, including over-the-counter medications (e.g., acid-controllers) and herbal preparations within two weeks of enrollment
  24. Smoking within 1 month of enrollment
  25. Alcohol or caffeine consumption within 72 hours of study drug administration
  26. Participation in a radio-labeled study within 12 months of enrollment
  27. Intake of radio-labeled drug substance or exposure to significant radiation
  28. Participation in any prior study with BMS747158

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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.
OTHER: Single Arm
Single arm PK study
Drug: [3H] BMS747158
Single bolus intravenous injection of [3H] BMS747158

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
To assess safety and the extent and route of [3H] radioactivity eliminated (mass balance) in urine and feces following a single intravenous (IV) dose of approximately 100 (±20) µCi of [3H] BMS747158 in healthy male subjects.
Time Frame: August 2009
August 2009

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 assess the pharmacokinetics (PK) of [3H] radioactivity and of [3H] BMS747158 in blood. To identify the major metabolites of [3H] BMS747158 present in blood, urine, and feces
Time Frame: August 2009
August 2009

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.
Lantheus Medical Imaging

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Debra A Mandarino, MD, Covance Clinical Laboratory Unit

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.
June 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.
July 1, 2009

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.
January 1, 2010

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).
June 24, 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.
June 29, 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.
June 30, 2009

Study Record Updates

Last Update Posted (ACTUAL)

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 10, 2020

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.
November 6, 2020

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, 2011

More Information

Terms related to this study

Keywords

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.
  • BMS747158-103

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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