Safety and Pharmacokinetic Study of BIO 300 Capsules

March 16, 2015 updated by: Humanetics Corporation

A Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profiles of BIO 300 Capsules in Healthy Male and Female Volunteers

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

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

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 500 BIO 300 capsule
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
EXPERIMENTAL: 1000 BIO 300 capsule
the second cohort will be treated with 1000 mg BIO 300 using the same PK sampling program
EXPERIMENTAL: 1500 BIO 300 capsule
the third cohort will be treated with 1500 mg BIO 300using the same PK sampling program
EXPERIMENTAL: 2000 BIO 300 capsule
the forth cohort will be treated with 2000 mg BIO 300using the same PK sampling program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety as assessed by lab work and adverse event monitoring
Time Frame: 1 month for females & 4 months for males
1 month for females & 4 months for males

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic assessment by analyzing patient serum for free and total BIO 300 content at multiple time points.
Time Frame: 7 days
7 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: John L Zenk, MD, Humanetics Corporation

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

June 1, 2007

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (ESTIMATE)

July 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

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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