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Safety and Pharmacokinetic Study of BIO 300 Capsules

Primary Purpose

Acute Radiation Syndrome

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIO 300 Capsules
Sponsored by
Humanetics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Radiation Syndrome focused on measuring Acute Radiation Syndrome, Hematopoietic Syndrome, Radiation Injury, BIO 300

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male and female subjects, age 18-64, who have signed the consent form

    • Subjects with a body mass index (BMI) 18-30 kg/m2
    • Subjects who are willing to abstain from sex or use a barrier method of birth control (Women 1 week, Men 4 months after leaving the trial)
    • Subjects with a negative pregnancy test and drug screen
    • Subjects with laboratory values within normal limits (CBC/differential, CMP, enzymes, ECG, vital signs, urinalysis)
    • Subjects with ability to comprehend and complete the questionnaires and forms
    • Subjects who are likely to comply with study procedures and test article consumption
    • Subjects whose schedules permit a 10-12 hour stay in the clinic followed by daily evaluations for one week (7 days)
    • Subjects who are available for a 14-day follow up phone call (women) and 4-month follow up phone call (men).
    • Subjects who are likely to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial
    • Subjects who are likely to follow the low isoflavone diet program

Exclusion Criteria:

  • · Subjects with any allergic reaction or sensitivity to soy, isoflavones, or any component of the test article product

    • Subjects who consume >5 alcoholic beverages per week
    • Subjects who are pregnant, lactating, or at risk of becoming pregnant
    • Subjects who have blood (or urine) levels outside the normal range for any of the hepatic, renal, hematologic, lipid or coagulation parameters measured.
    • Subjects on Hormone Replacement Therapy or Birth Control Pills within the past three months.
    • Subjects on any other clinical trial or experimental treatment in the past 3 months
    • Subjects with a history of diabetes (Type 1 or Type 2 diabetes mellitus) or other endocrine disorders, uncontrolled hypertension, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or HIV infection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    500 BIO 300 capsule

    1000 BIO 300 capsule

    1500 BIO 300 capsule

    2000 BIO 300 capsule

    Arm Description

    The first cohort will receive one 500 BIO 300 capsule and pharmacokinetic blood sampling will be conducted over the first 4 days in an outpatient setting

    the second cohort will be treated with 1000 mg BIO 300 using the same PK sampling program

    the third cohort will be treated with 1500 mg BIO 300using the same PK sampling program

    the forth cohort will be treated with 2000 mg BIO 300using the same PK sampling program

    Outcomes

    Primary Outcome Measures

    Safety as assessed by lab work and adverse event monitoring

    Secondary Outcome Measures

    Pharmacokinetic assessment by analyzing patient serum for free and total BIO 300 content at multiple time points.

    Full Information

    First Posted
    July 19, 2007
    Last Updated
    March 16, 2015
    Sponsor
    Humanetics Corporation
    Collaborators
    United States Department of Defense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00504335
    Brief Title
    Safety and Pharmacokinetic Study of BIO 300 Capsules
    Official Title
    A Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profiles of BIO 300 Capsules in Healthy Male and Female Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2007 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Humanetics Corporation
    Collaborators
    United States Department of Defense

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for use starting at 500 mg.
    Detailed Description
    This clinical trial will assess the safety and PK of BIO 300 capsules at doses expected to deliver a radioprotective or therapeutic effect in humans. Humanetics is planning to conduct this Phase I, single dose, dose-escalation (500, 1000, 1500, and 2000 milligrams) study of the safety, tolerability and pharmacokinetics of BIO 300 by recruiting approximately 24 healthy men and women between the ages of 18 and 64 to be enrolled in cohorts of 6 subjects per group. The first cohort will receive one 500 mg BIO 300 capsule and pharmacokinetic blood sampling will be conducted over the first 4 days in an outpatient setting at a clinic skilled in this type of Phase I trial. Blood samples will be analyzed for BIO 300 levels, hematology, chemistry, lipid profiles, phosphorus, clotting factors and fibrinogen as well as pancreatic lipase and amylase. Urinalysis will assess kidney function as well as creatinine clearance and BIO 300 clearance. All subjects will be monitored for adverse events and the safety of BIO 300 capsules will be evaluated in this setting. After review of all safety information and provided no clinically significant negative findings are revealed, the second cohort will be treated with 1000mg BIO 300 (two 500mg capsules) using the same PK sampling program. Again safety concerns will be reviewed and provided no clinically significant negative findings are revealed, the third and fourth cohort will be treated with 1500 and 2000 mg, respectively, of BIO 300 using the same PK sampling program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Radiation Syndrome
    Keywords
    Acute Radiation Syndrome, Hematopoietic Syndrome, Radiation Injury, BIO 300

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    500 BIO 300 capsule
    Arm Type
    Experimental
    Arm Description
    The first cohort will receive one 500 BIO 300 capsule and pharmacokinetic blood sampling will be conducted over the first 4 days in an outpatient setting
    Arm Title
    1000 BIO 300 capsule
    Arm Type
    Experimental
    Arm Description
    the second cohort will be treated with 1000 mg BIO 300 using the same PK sampling program
    Arm Title
    1500 BIO 300 capsule
    Arm Type
    Experimental
    Arm Description
    the third cohort will be treated with 1500 mg BIO 300using the same PK sampling program
    Arm Title
    2000 BIO 300 capsule
    Arm Type
    Experimental
    Arm Description
    the forth cohort will be treated with 2000 mg BIO 300using the same PK sampling program
    Intervention Type
    Drug
    Intervention Name(s)
    BIO 300 Capsules
    Primary Outcome Measure Information:
    Title
    Safety as assessed by lab work and adverse event monitoring
    Time Frame
    1 month for females & 4 months for males
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetic assessment by analyzing patient serum for free and total BIO 300 content at multiple time points.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male and female subjects, age 18-64, who have signed the consent form Subjects with a body mass index (BMI) 18-30 kg/m2 Subjects who are willing to abstain from sex or use a barrier method of birth control (Women 1 week, Men 4 months after leaving the trial) Subjects with a negative pregnancy test and drug screen Subjects with laboratory values within normal limits (CBC/differential, CMP, enzymes, ECG, vital signs, urinalysis) Subjects with ability to comprehend and complete the questionnaires and forms Subjects who are likely to comply with study procedures and test article consumption Subjects whose schedules permit a 10-12 hour stay in the clinic followed by daily evaluations for one week (7 days) Subjects who are available for a 14-day follow up phone call (women) and 4-month follow up phone call (men). Subjects who are likely to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial Subjects who are likely to follow the low isoflavone diet program Exclusion Criteria: · Subjects with any allergic reaction or sensitivity to soy, isoflavones, or any component of the test article product Subjects who consume >5 alcoholic beverages per week Subjects who are pregnant, lactating, or at risk of becoming pregnant Subjects who have blood (or urine) levels outside the normal range for any of the hepatic, renal, hematologic, lipid or coagulation parameters measured. Subjects on Hormone Replacement Therapy or Birth Control Pills within the past three months. Subjects on any other clinical trial or experimental treatment in the past 3 months Subjects with a history of diabetes (Type 1 or Type 2 diabetes mellitus) or other endocrine disorders, uncontrolled hypertension, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or HIV infection.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John L Zenk, MD
    Organizational Affiliation
    Humanetics Corporation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Safety and Pharmacokinetic Study of BIO 300 Capsules

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