NCT01948362

A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Sulforadex® in Healthy Male Subjects

Completed Phase 1 Last updated 18 September 2013

What this trial tests

Phase 1 trial testing Sulforadex in Stage, Prostate Cancer in 29 participants. Completed in 1 February 2013.

Timeline

1 November 2012

Primary endpoint
1 February 2013

1 February 2013

Quick facts

Lead sponsor	Evgen Pharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	29
Start date	1 November 2012
Primary completion	1 February 2013
Estimated completion	1 February 2013
Sites	1 location across United Kingdom

Drugs / interventions tested

• Sulforadex — full drug profile →
• Alpha cyclodextrin — full drug profile →

Conditions studied

• Stage, Prostate Cancer — all drugs for Stage, Prostate Cancer →

Sponsor

Evgen Pharma — full company profile →

Who can join

Adults 18 to 45, male only, with Stage, Prostate Cancer. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Activators and Inhibitors of NRF2: A Review of Their Potential for Clinical Development.
   Robledinos-Antón N, Fernández-Ginés R, Manda G, Cuadrado A. · · 2019 · cited 443× · PMID 31396308 · DOI 10.1155/2019/9372182
2. Dietary Sulforaphane in Cancer Chemoprevention: The Role of Epigenetic Regulation and HDAC Inhibition.
   Tortorella SM, Royce SG, Licciardi PV, Karagiannis TC. · · 2015 · cited 131× · PMID 25364882 · DOI 10.1089/ars.2014.6097
3. Role of Nrf2 Signaling Cascade in Breast Cancer: Strategies and Treatment.
   Kumar H, Kumar RM, Bhattacharjee D, Somanna P, et al · · 2022 · cited 48× · PMID 35571115 · DOI 10.3389/fphar.2022.720076
4. Broccoli-Derived Sulforaphane and Chemoprevention of Prostate Cancer: From Bench to Bedside.
   Amjad AI, Parikh RA, Appleman LJ, Hahm ER, et al · · 2015 · cited 42× · PMID 26557472 · DOI 10.1007/s40495-015-0034-x
5. Study protocol for SFX-01 after subarachnoid haemorrhage (SAS): a multicentre randomised double-blinded, placebo controlled trial.
   Zolnourian AH, Franklin S, Galea I, Bulters DO. · · 2020 · cited 30× · PMID 32217557 · DOI 10.1136/bmjopen-2018-028514
6. Cyclodextrin nanoparticles for diagnosis and potential cancer therapy: A systematic review.
   Karthic A, Roy A, Lakkakula J, Alghamdi S, et al · · 2022 · cited 29× · PMID 36158215 · DOI 10.3389/fcell.2022.984311
7. Short-chain acyl post-translational modifications in cancers: Mechanisms, roles, and therapeutic implications.
   Wu T, Zhao Y, Zhang X, Wang Y, et al · · 2025 · cited 23× · PMID 40703012 · DOI 10.1002/cac2.70048
8. The Role of NRF2 in Cerebrovascular Protection: Implications for Vascular Cognitive Impairment and Dementia (VCID).
   Hu Y, Zhang F, Ikonomovic M, Yang T. · · 2024 · cited 10× · PMID 38612642 · DOI 10.3390/ijms25073833