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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

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

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

NCT ID

NCT00504335

First Posted

July 19, 2007

Last Updated

March 16, 2015

Sponsor

Humanetics Corporation

Collaborators

United States Department of Defense

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

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

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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