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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
Sponsor:
Information provided by (Responsible Party):
Evgen Pharma

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 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

Resource links provided by the National Library of Medicine


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




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).




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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.

Information from the National Library of Medicine

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


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

Responsible Party: Evgen Pharma
ClinicalTrials.gov Identifier: NCT02055716     History of Changes
Other Study ID Numbers: EVG002N
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015