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Sulforadex in Healthy Volunteers SAD

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

Tracking Information
First Submitted Date  ICMJE September 11, 2013
First Posted Date  ICMJE September 23, 2013
Last Update Posted Date September 23, 2013
Study Start Date  ICMJE November 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sulforadex in Healthy Volunteers SAD
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stage, Prostate Cancer
Intervention  ICMJE
  • Drug: Sulforadex
    Active compound
    Other Name: Stabilised sulforaphane
  • Drug: Alpha cyclodextrin
    Placebo control
Study Arms  ICMJE
  • Active Comparator: Sulforadex
    Active compound
    Intervention: Drug: Sulforadex
  • Experimental: alpha Cyclodextrin
    Placebo control arm
    Intervention: Drug: Alpha cyclodextrin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2013)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01948362
Other Study ID Numbers  ICMJE EVG001N
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Evgen Pharma
Study Sponsor  ICMJE Evgen Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jörg Täube, MD FFPM Richmond Pharmacology
PRS Account Evgen Pharma
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP