Safety and Pharmacokinetic Study of BIO 300 Capsules

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Humanetics Corporation
ClinicalTrials.gov Identifier:
NCT00504335
First received: July 19, 2007
Last updated: October 2, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Acute Radiation Syndrome
Drug: BIO 300 Capsules
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profiles of BIO 300 Capsules in Healthy Male and Female Volunteers

Further study details as provided by Humanetics Corporation:

Primary Outcome Measures:
  • Safety as assessed by lab work and adverse event monitoring [ Time Frame: 1 month for females & 4 months for males ]

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

Enrollment: 24
Study Start Date: June 2007
Study Completion Date: October 2007
Arms Assigned Interventions
500, 1000, 1500, 2000
This study will have 4 arms or cohorts. Each cohort will be tested at an escalating dose of BIO 300; 500 mg, 1000 mg, 1500 mg & 2000 mg.
Drug: BIO 300 Capsules

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504335

Locations
United States, Minnesota
MAPS Applied Research Center
Edina, Minnesota, United States, 55435
Sponsors and Collaborators
Humanetics Corporation
Investigators
Principal Investigator: John L Zenk, MD Humanetics Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00504335     History of Changes
Other Study ID Numbers: MARC006-025
Study First Received: July 19, 2007
Last Updated: October 2, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Humanetics Corporation:
Acute Radiation Syndrome
Hematopoietic Syndrome
Radiation Injury
BIO 300

Additional relevant MeSH terms:
Radiation Injuries
Acute Radiation Syndrome
Wounds and Injuries

ClinicalTrials.gov processed this record on August 26, 2014