- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504335
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
Conditions
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MARC006-025
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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