Sulforadex in Healthy Volunteers SAD

NCT01948362 | Completed Phase 1 DMC

• 1 other identifier: EVG001N
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and tolerability of single escalating doses of Sulforadex® in healthy male volunteers.

Conditions

Stage, Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Safety

  Safety assessments will include standard laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs, physical examinations, 12-lead ECG, telemetry and AE monitoring.

  2 days

Study Arms (2)

Sulforadex

ACTIVE COMPARATOR

Active compound

Drug: Sulforadex

alpha Cyclodextrin

EXPERIMENTAL

Placebo control arm

Drug: Alpha cyclodextrin

Interventions

Sulforadex DRUG

Active compound

Also known as: Stabilised sulforaphane

Sulforadex

Alpha cyclodextrin DRUG

Placebo control

alpha Cyclodextrin

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Subjects could not refrain from eating brassica vegetables or using brassica containing supplements for at least 7 days prior to the drug administration.
• History or clinical evidence of clinically significant disease or any condition or disease that affects drug absorption, distribution or excretion.
• 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.
• 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.
• Any history or current evidence of clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.
• Positive screen for Hepatitis B (Hepatitis B surface Antigen, HBsAG), Hepatitis C (Hepatitis C Antibody, anti-HCV) or HIV.
• Confirmed positive results from urine drug screen at screening and on admission (Day
• ) 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).
• 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.
• Subject was mentally handicapped.
• Participation in another drug trial within 90 days prior to first drug administration.
• 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.
• Subjects who had donated more than 500 mL of blood within 90 days prior to drug administration.
• 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.
• 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).

Sponsors & Collaborators

• Evgen Pharma: lead

Study Sites (1)

Richmond Pharmacology

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 Täube, MD FFPM

  Richmond Pharmacology

  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: September 11, 2013
• First Posted: September 23, 2013
• Study Start: November 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

GB (1)