Safety and Pharmacokinetic Study of BIO 300 Capsules

NCT00504335 | Completed Phase 1

• 1 other identifier: MARC006-025
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Radiation Syndrome

Keywords

Acute Radiation Syndrome; Hematopoietic Syndrome; Radiation Injury; BIO 300

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by lab work and adverse event monitoring

  1 month for females & 4 months for males

Secondary Outcomes (1)

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

  7 days

Study Arms (4)

500 BIO 300 capsule

EXPERIMENTAL

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

Drug: BIO 300 Capsules

1000 BIO 300 capsule

EXPERIMENTAL

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

Drug: BIO 300 Capsules

1500 BIO 300 capsule

EXPERIMENTAL

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

Drug: BIO 300 Capsules

2000 BIO 300 capsule

EXPERIMENTAL

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

Drug: BIO 300 Capsules

Interventions

BIO 300 Capsules DRUG

1000 BIO 300 capsule; 1500 BIO 300 capsule; 2000 BIO 300 capsule; 500 BIO 300 capsule

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• · 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.

Sponsors & Collaborators

• Humanetics Corporation: lead
• United States Department of Defense: collaborator

MeSH Terms

Conditions

Acute Radiation Syndrome; Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• John L Zenk, MD

  Humanetics Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 17, 2015

Record last verified: 2015-03