Sulforadex in Healthy Human Males MAD

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055716
• Other study ID #: EVG002N
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2014
• Last updated: February 9, 2015
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Evgen Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• Sulforadex

• alpha-cyclodextrin

Locations

Country	Name	City	State
United Kingdom	Richmond Pharmacology Limited	London

Sponsors (1)

Lead Sponsor	Collaborator
Evgen Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	Safety assessments will include standard laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs, physical examinations, 12-lead ECG, telemetry and AE monitoring.	7 days	Yes
Secondary	Area under the plasma concentration versus time curve (AUC) of sulforaphane	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).	time 0, 30 min 1 2 4 8 12 & 24 hrs post dose on days 1,2 & 7	No