Sulforadex in Healthy Human Males MAD

• ClinicalTrials.gov Identifier: NCT02055716
• Recruitment Status: Completed
• First Posted: February 5, 2014
• Last Update Posted: February 10, 2015
• Sponsor: Evgen Pharma
• Information provided by (Responsible Party): Evgen Pharma

Study Description

Brief Summary:

To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male volunteers over 7 days with qd or bid dosing

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Sulforadex; Drug: alpha-cyclodextrin	Phase 1

Detailed Description:

This study will be conducted in a randomised, double-blind, placebo-controlled design with multiple ascending doses of Sulforadex® administered qd [once daily] or bid [twice daily]) to healthy male subjects between 18 to 45 years of age.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: alpha-cyclodextrin; A placebo comparator composed of the same acid resistant HPMC capsules filled with 300mg of alpha cyclodextrin	Drug: alpha-cyclodextrin
Experimental: Sulforadex; 100mg or 300mg size 00 acid resistant HPMC capsules	Drug: Sulforadex; Other Name: Stabilised sulforaphane

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Subject is a healthy male of any race aged 18 to 45 years, inclusive, at screening.
2. Subject has a BMI of 18 - 25 kg/m2 inclusive at screening.
3. Subjects must agree to use acceptable methods of contraception,
4. 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.
5. 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.

Exclusion Criteria:

1. 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.
2. Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
3. 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.
4. 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.
5. History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
6. 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).
7. 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).
8. History or clinical evidence of alcohol or drug abuse.
9. Mentally handicapped.

Contacts and Locations

Locations

United Kingdom

Richmond Pharmacology Limited

London, United Kingdom, SW17 0RE

Sponsors and Collaborators

Evgen Pharma

Investigators

• Principal Investigator: Jörg Täubel, MD FFPM; Richmond Pharmacology Limited

More Information

• Responsible Party: Evgen Pharma
• ClinicalTrials.gov Identifier: NCT02055716
• Other Study ID Numbers: EVG002N
• First Posted: February 5, 2014
• Last Update Posted: February 10, 2015
• Last Verified: February 2015

Additional relevant MeSH terms:

Sulforaphane; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Anticarcinogenic Agents; Protective Agents; Physiological Effects of Drugs; Antineoplastic Agents