Healthy, no Evidence of DiseasePhase 1NCT00679094
Bowman-Birk Inhibitor Concentrate in Healthy Men
A Phase 1 study testing Bowman-Birk inhibitor concentrate, pharmacological study and laboratory biomarker analysis in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- Bowman-Birk inhibitor concentrate, pharmacological study and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male participant recruited from the Philadelphia, Pennsylvania metropolitan area
- ECOG performance status 0-2
- WBC ≥ 3,000/uL
- Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and basophils) normal
- Platelet count normal
- Hemoglobin normal
Show all 34Show fewer
- Hematocrit normal
- RBC normal
- Creatinine normal
- Bilirubin normal
- ALT and AST normal
- Amylase and lipase normal
- Glucose normal
- Cholesterol normal
- Triglycerides normal
- Non-smoker
- Former smokers are eligible provided they have not smoked within the past 3 months
- Within 15% of ideal body weight based on standard weight tables
- No vegetarians or individuals who normally ingest large amounts of soy products, defined as two or more servings of tofu, soy milk, or other primarily soy-based food per day
- No prior allergy or adverse reaction to soybeans
- No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
- No prior diagnosis of pancreatitis, pancreatic carcinoma, pancreatic adenoma, diabetes mellitus, obstruction of pancreatic ducts, or amyloidosis
- No history of heart disease
- EKG normal (normal variants allowed)
- No evidence of psychiatric problems
- No history of excessive alcohol consumption (i.e., an average of > 2 alcoholic beverages per day)
- No alcohol consumption within the past 3 days
- No history of any medical condition that could influence gastrointestinal uptake of the drug
- No history of chronic medical condition
- No evidence of another life-threatening disease
- More than 12 months since prior chemotherapy
- More than 1 month since prior experimental drugs
- More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of nonsteroidal anti-inflammatory drugs (NSAIDs)
- More than 2 weeks since prior and no concurrent multivitamin tablets (or other vitamin supplements) of > 2 per day
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase I Single Dose Safety and Pharmacokinetic Study of a New Formulation of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
Read the detailed description
OBJECTIVES:
- Assess the toxicity of single-dose Bowman-Birk Inhibitor Concentrate (BBIC) when administered as a suspension in orange juice in healthy male participants.
II. Determine the appropriate dose range and doses to be used in a subsequent phase I multiple-dose BBIC study that will be based upon the data gathered from this phase I single-dose study.
III. Characterize the pharmacokinetics of single-dose BBIC.
OUTLINE: This is a dose-escalation study of Bowman-Birk Inhibitor Concentrate (BBIC). Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo or BBIC.
Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet.
Participants undergo blood and urine sample collection periodically for pharmacokinetic studies. Samples are analyzed by a sandwich enzyme-linked immunosorbent assay to measure concentrations of BBIC and its metabolites in serum and urine.
After completion of study treatment, participants are followed once weekly for 4 weeks.
- Conditions
- Healthy, no Evidence of Disease
- Being tested
- Bowman-Birk inhibitor concentrate, placebo, pharmacological study, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowman-Birk inhibitor concentrateDrug
Also called BBIC
Given orally
placeboOther
Also called PLCB
Given orally
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet. Receives: Drug: Bowman-Birk inhibitor concentrate; Other: placebo; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase II dose, defined as the highest dose level at which none of the subjects in that dose group experience DLT as measured by NCI Common Toxicity Criteria
Measured: Up to 48 hours
Pharmacokinetics of BBIC in the serum as measured by a sandwich enzyme-linked immunosorbent assay
Presented in a form of time course of serum BBI concentration after BBIC ingestion by the study subjects and peak concentration (Cmax), time to reach peak concentration (Tmax), area under the curve (AUC), and elimination rate constant (kel) and serum half-lives (t1/2) will be calculated for each subject. Mean, median, and 95% confidence interval will then be calculated for each parameter for each dose group. The relationship between dose and the above parameters will be investigated using simple linear regression.
Measured: Immediately before BBIC administration and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lilie Lin, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679094
- Sponsor's protocol ID
- NCI-2009-00865
- Other IDs
- NCI-2009-00865, CDR0000595863, UPCC-N01-CN-25118-2, UPCC-805938, UPCC-805938, N01-CN-25118-2, P30CA016520, N01CN25118
- Status last verified
- Dec 2016
- First submitted
- 14 May 2008
- Last updated
- 29 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Single Dose Safety and Pharmacokinetic Study of a New Formulation of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age
- ClinicalTrials.gov ID
- NCT00679094
- Acronym / sponsor ID
- NCI-2009-00865
- Conditions
- Healthy, no Evidence of Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
Detailed description
OBJECTIVES:
- Assess the toxicity of single-dose Bowman-Birk Inhibitor Concentrate (BBIC) when administered as a suspension in orange juice in healthy male participants.
II. Determine the appropriate dose range and doses to be used in a subsequent phase I multiple-dose BBIC study that will be based upon the data gathered from this phase I single-dose study.
III. Characterize the pharmacokinetics of single-dose BBIC.
OUTLINE: This is a dose-escalation study of Bowman-Birk Inhibitor Concentrate (BBIC). Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo or BBIC.
Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet.
Participants undergo blood and urine sample collection periodically for pharmacokinetic studies. Samples are analyzed by a sandwich enzyme-linked immunosorbent assay to measure concentrations of BBIC and its metabolites in serum and urine.
After completion of study treatment, participants are followed once weekly for 4 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Bowman-Birk inhibitor concentrate, Other: placebo, Other: pharmacological study, Other: laboratory biomarker analysisParticipants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Healthy male participant recruited from the Philadelphia, Pennsylvania metropolitan area
- ECOG performance status 0-2
- WBC ≥ 3,000/uL
- Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and basophils) normal
- Platelet count normal
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bowman-Birk inhibitor concentrateAlso: BBICGiven orally | Drug | Arm I |
| placeboAlso: PLCBGiven orally | Other | Arm I |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I |
| laboratory biomarker analysisCorrelative studies | Other | Arm I |
Primary outcome
Recommended phase II dose, defined as the highest dose level at which none of the subjects in that dose group experience DLT as measured by NCI Common Toxicity Criteria
Time frame: Up to 48 hours
Pharmacokinetics of BBIC in the serum as measured by a sandwich enzyme-linked immunosorbent assay
Time frame: Immediately before BBIC administration and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 after administration
Presented in a form of time course of serum BBI concentration after BBIC ingestion by the study subjects and peak concentration (Cmax), time to reach peak concentration (Tmax), area under the curve (AUC), and elimination rate constant (kel) and serum half-lives (t1/2) will be calculated for each subject. Mean, median, and 95% confidence interval will then be calculated for each parameter for each dose group. The relationship between dose and the above parameters will be investigated using simple linear regression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilie Lin principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bowman-Birk inhibitor concentrate, pharmacological study and laboratory biomarker analysis in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended phase II dose, defined as the highest dose level at which none of the subjects in that dose group experience DLT as measured by NCI Common Toxicity Criteria (time frame: Up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.