Sulforadex in Healthy Volunteers SAD

• ClinicalTrials.gov Identifier: NCT01948362
• Recruitment Status: Completed
• First Posted: September 23, 2013
• Last Update Posted: September 23, 2013
• Sponsor: Evgen Pharma
• Information provided by (Responsible Party): Evgen Pharma

Tracking Information

• First Submitted Date: September 11, 2013
• First Posted Date: September 23, 2013
• Last Update Posted Date: September 23, 2013
• Study Start Date: November 2012
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 18, 2013)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sulforadex in Healthy Volunteers SAD
• 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
• Brief Summary: 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stage, Prostate Cancer

Intervention

• Drug: Sulforadex
  Active compound
  Other Name: Stabilised sulforaphane
• Drug: Alpha cyclodextrin
  Placebo control

Study Arms

• Active Comparator: Sulforadex
  Active compound
  Intervention: Drug: Sulforadex
• Experimental: alpha Cyclodextrin
  Placebo control arm
  Intervention: Drug: Alpha cyclodextrin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 18, 2013): 29
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Healthy male subjects aged between 18 and 45 years (inclusive) at screening.
2. Had a Body Mass Index (BMI) between 18.5 and 25.0 kg/m2 (inclusive) at screening.
3. Subjects agreed to use acceptable methods of contraception

Exclusion Criteria:

1. Subjects could not refrain from eating brassica vegetables or using brassica containing supplements for at least 7 days prior to the drug administration.
2. History or clinical evidence of clinically significant disease or any condition or disease that affects drug absorption, distribution or excretion.
3. 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.
4. 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.
5. Any history or current evidence of clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.
6. Positive screen for Hepatitis B (Hepatitis B surface Antigen, HBsAG), Hepatitis C (Hepatitis C Antibody, anti-HCV) or HIV.

7. 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).

8. 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.
9. Subject was mentally handicapped.
10. Participation in another drug trial within 90 days prior to first drug administration.
11. 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.
12. Subjects who had donated more than 500 mL of blood within 90 days prior to drug administration.
13. 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.
14. 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).
15. Any circumstances or condition(s) that in the opinion of the Investigator would compromise full participation in the trial or compliance with the protocol.
16. Subjects with legal incapacity or limited legal capacity at screening.
17. Subjects who were vegetarians, vegans or have medical dietary restrictions.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01948362
• Other Study ID Numbers: EVG001N
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Evgen Pharma
• Original Responsible Party: Same as current
• Current Study Sponsor: Evgen Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jörg Täube, MD FFPM; Richmond Pharmacology

• PRS Account: Evgen Pharma
• Verification Date: September 2013