Sulforadex in Healthy Human Males MAD

NCT02055716 | Completed Phase 1 DMC

• 1 other identifier: EVG002N
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) of sulforaphane

  time 0, 30 min 1 2 4 8 12 & 24 hrs post dose on days 1,2 & 7

Study Arms (2)

alpha-cyclodextrin

PLACEBO COMPARATOR

A placebo comparator composed of the same acid resistant HPMC capsules filled with 300mg of alpha cyclodextrin

Drug: alpha-cyclodextrin

Sulforadex

EXPERIMENTAL

100mg or 300mg size 00 acid resistant HPMC capsules

Drug: Sulforadex

Interventions

Sulforadex DRUG

Also known as: Stabilised sulforaphane

Sulforadex

alpha-cyclodextrin DRUG

alpha-cyclodextrin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Evgen Pharma: lead

Study Sites (1)

Richmond Pharmacology Limited

London, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

alpha-cyclodextrin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jörg Täubel, MD FFPM

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: February 5, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

GB (1)