Stage, Prostate CancerPhase 1NCT01948362
Sulforadex in Healthy Volunteers SAD
A Phase 1 study testing Sulforadex and Alpha cyclodextrin in people with Stage, Prostate Cancer, run by Evgen Pharma at 1 site in United Kingdom.
Trial summary
To determine the safety and tolerability of single escalating doses of Sulforadex® in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stage, Prostate Cancer
- What is being tested?
- Sulforadex and Alpha cyclodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Feb 2013
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged between 18 and 45 years (inclusive) at screening.
- Had a Body Mass Index (BMI) between 18.5 and 25.0 kg/m2 (inclusive) at screening.
- Subjects agreed to use acceptable methods of contraception
Who cannot join
- Subjects could not refrain from eating brassica vegetables or using brassica containing supplements for at least 7 days prior to the drug administration.
- History or clinical evidence of clinically significant disease or any condition or disease that affects drug absorption, distribution or excretion.
- Any history of clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
- Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening and Day -1) and 24-hour 5-lead Holter ECG (at screening) which in the opinion of the Investigator interfered with the ECG analysis.
- Any history or current evidence of clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.
- Positive screen for Hepatitis B (Hepatitis B surface Antigen, HBsAG), Hepatitis C (Hepatitis C Antibody, anti-HCV) or HIV.
Show all 18Show fewer
- Confirmed positive results from urine drug screen at screening and on admission (Day
- -1) indicating drug abuse including: amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, tricyclic antidepressants and methadone or a confirmed positive alcohol breath test at screening and on admission (Day -1).
- History or clinical evidence of alcoholism or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 14 units if female and 21 units if male (Using alcohol tracker http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx); drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms.
- Subject was mentally handicapped.
- Participation in another drug trial within 90 days prior to first drug administration.
- Use of any medication (including over-the-counter [OTC] medication) within 2 weeks prior to admission (Day 1) or within 10 times the elimination half-life of the respective drug or anticipated concomitant medication during the treatment periods. Limited amounts of paracetamol were allowed to treat AEs.
- Subjects who had donated more than 500 mL of blood within 90 days prior to drug administration.
- Smoking more than 10 cigarettes or equivalent amount of tobacco per day and subjects who could not stop smoking for the duration of the study whilst in the CPU.
- Treatment with herbal or sulforaphane containing supplements during the 7 days prior to dosing, or use of vitamins during 48 hours prior to admission (Day -1).
- Any circumstances or condition(s) that in the opinion of the Investigator would compromise full participation in the trial or compliance with the protocol.
- Subjects with legal incapacity or limited legal capacity at screening.
- Subjects who were vegetarians, vegans or have medical dietary restrictions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Sulforadex® in Healthy Male Subjects
To determine the safety and tolerability of single escalating doses of Sulforadex® in healthy male volunteers.
Read the detailed description
This study will be conducted in a randomised, double-blind, placebo-controlled design with single ascending doses of Sulforadex® administered to healthy male subjects between 18 to 45 years of age. Each healthy subject will receive verbal and written information followed by signing of the Informed Consent Form (ICF).
Subjects will be screened within 21 days prior to admission. At this visit a medical examination will be performed to assess eligibility of the healthy subject. Screening will be conducted over 1 day or may be divided into more than 1 day. The first cohort of the study will commence with one sentinel group. The subsequent groups may be dosed together without sentinel dosing. The study is expected to have 5 cohorts with a total of 29 healthy male subjects:
- Conditions
- Stage, Prostate Cancer
- Being tested
- Sulforadex, Alpha cyclodextrin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforadexDrug
Also called Stabilised sulforaphane
Active compound
Alpha cyclodextrinDrug
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| Sulforadex | Active comparator | Active compound Receives: Drug: Sulforadex |
| alpha Cyclodextrin | Experimental | Placebo control arm Receives: Drug: Alpha cyclodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety assessments will include standard laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs, physical examinations, 12-lead ECG, telemetry and AE monitoring.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage, Prostate CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evgen Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jörg Täube, MD FFPM, Principal investigator, Richmond Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948362
- Sponsor's protocol ID
- EVG001N
- Status last verified
- Sep 2013
- First submitted
- 11 Sep 2013
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Sulforadex® in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01948362
- Acronym / sponsor ID
- EVG001N
- Conditions
- Stage, Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Evgen PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 23 Sep 2013 (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.
To determine the safety and tolerability of single escalating doses of Sulforadex® in healthy male volunteers.
Detailed description
This study will be conducted in a randomised, double-blind, placebo-controlled design with single ascending doses of Sulforadex® administered to healthy male subjects between 18 to 45 years of age. Each healthy subject will receive verbal and written information followed by signing of the Informed Consent Form (ICF).
Subjects will be screened within 21 days prior to admission. At this visit a medical examination will be performed to assess eligibility of the healthy subject. Screening will be conducted over 1 day or may be divided into more than 1 day. The first cohort of the study will commence with one sentinel group. The subsequent groups may be dosed together without sentinel dosing. The study is expected to have 5 cohorts with a total of 29 healthy male subjects:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulforadex | Active comparator | Drug: SulforadexActive compound |
| alpha Cyclodextrin | Experimental | Drug: Alpha cyclodextrinPlacebo control arm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged between 18 and 45 years (inclusive) at screening.
- Had a Body Mass Index (BMI) between 18.5 and 25.0 kg/m2 (inclusive) at screening.
- Subjects agreed to use acceptable methods of contraception
Key exclusion criteria (18 listed)
- Subjects could not refrain from eating brassica vegetables or using brassica containing supplements for at least 7 days prior to the drug administration.
- History or clinical evidence of clinically significant disease or any condition or disease that affects drug absorption, distribution or excretion.
- Any history of clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
- Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening and Day -1) and 24-hour 5-lead Holter ECG (at screening) which in the opinion of the Investigator interfered with the ECG analysis.
- Any history or current evidence of clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.
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 |
|---|---|---|
| SulforadexAlso: Stabilised sulforaphaneActive compound | Drug | Sulforadex |
| Alpha cyclodextrinPlacebo control | Drug | alpha Cyclodextrin |
Primary outcome
Safety
Time frame: 2 days
Safety assessments will include standard laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs, physical examinations, 12-lead ECG, telemetry and AE monitoring.
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 23 Sep 2013.
Related trials for Stage, Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Jörg Täube, MD FFPM principal investigator
Richmond Pharmacology
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 Sulforadex and Alpha cyclodextrin in people with Stage, Prostate Cancer, run by Evgen Pharma at 1 site in United Kingdom.
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 3 inclusion and 18 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 23 Sep 2013. 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 Kingdom. 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?
Safety (time frame: 2 days). 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 23 Sep 2013.