Sulforadex in Healthy Human Males MAD
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|ClinicalTrials.gov Identifier: NCT02055716|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : February 10, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Sulforadex Drug: alpha-cyclodextrin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Sulforadex® in Healthy Male Subjects Following Daily Dosing for 7 Days|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||May 2014|
Placebo Comparator: alpha-cyclodextrin
A placebo comparator composed of the same acid resistant HPMC capsules filled with 300mg of alpha cyclodextrin
100mg or 300mg size 00 acid resistant HPMC capsules
Other Name: Stabilised sulforaphane
- Number of participants with adverse events [ Time Frame: 7 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.
- Area under the plasma concentration versus time curve (AUC) of sulforaphane [ Time Frame: time 0, 30 min 1 2 4 8 12 & 24 hrs post dose on days 1,2 & 7 ]
Plasma sulforaphane concentrations will be measured by LCMS/MS assay.
• Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t).
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- Subject is a healthy male of any race aged 18 to 45 years, inclusive, at screening.
- Subject has a BMI of 18 - 25 kg/m2 inclusive at screening.
- Subjects must agree to use acceptable methods of contraception,
- Subjects should not donate sperm from the time of the first administration of treatment or study medication until 3 months following administration of the last treatment or dose of study medication.
- Subjects must be capable of understanding and complying with the requirements of the protocol and must have signed the ICF prior to undergoing any study-related procedures.
- All subjects must refrain from eating brassica vegetables or using brassica containing supplements for at least 7 days prior to the drug administration. Brassica vegetables include cabbage, cauliflower, horseradish, landcress, Ethiopian mustard, kale, collard greens, Chinese broccoli, brussels sprouts, Kohlrabi broccoli, broccoli flower, broccoli romanesco, wild broccoli, bok choy, Komatsuna, mizuna, rapini, flowering cabbage, Chinese cabbage, Napa cabbage, turnip root, rutabaga, canola/rape seed, Siberian kale, wrapped heart mustard cabbage, mustard seed (brown, black, white), tatsoi, rocket (arugula), garden cress, water cress, radish, daikon and wasabi.
- Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
- Any 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.
- ECG abnormalities in the standard 12-lead ECG (at screening) which in the opinion of the Investigator is clinically relevant or will interfere with the ECG analysis.
- History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
- Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti Hepatitis core antibody (anti HBc Ig G [and anti HBc IgM if IgG is positive], Hepatitis C virus antibodies (anti HCV), and human immunodeficiency virus HIV 1 and 2 antibodies (anti HIV 1/2).
- Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, tricyclic antidepressants and methadone) or from the alcohol breath test at screening and on admission (Day -1).
- History or clinical evidence of alcohol or drug abuse.
- Mentally handicapped.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055716
|Richmond Pharmacology Limited|
|London, United Kingdom, SW17 0RE|
|Principal Investigator:||Jörg Täubel, MD FFPM||Richmond Pharmacology Limited|
|Responsible Party:||Evgen Pharma|
|Other Study ID Numbers:||
|First Posted:||February 5, 2014 Key Record Dates|
|Last Update Posted:||February 10, 2015|
|Last Verified:||February 2015|
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases
Physiological Effects of Drugs