NCT02055716

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

Completed Phase 1 Last updated 9 February 2015

What this trial tests

Phase 1 trial testing Sulforadex in Prostate Cancer in 18 participants. Completed in 1 May 2014.

Timeline

1 January 2014

Primary endpoint
1 April 2014

1 May 2014

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	18
Start date	1 January 2014
Primary completion	1 April 2014
Estimated completion	1 May 2014
Sites	1 location across United Kingdom

Drugs / interventions tested

• Sulforadex — full drug profile →
• alpha-cyclodextrin

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Evgen Pharma — full company profile →

Who can join

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

What's being measured

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

• 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.

Sponsor's own description

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

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. 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
3. 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
4. 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
5. 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
6. 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
7. Health position paper and redox perspectives - Bench to bedside transition for pharmacological regulation of NRF2 in noncommunicable diseases.
   Cuadrado A, Cazalla E, Bach A, Bathish B, et al · · 2025 · cited 9× · PMID 40059038 · DOI 10.1016/j.redox.2025.103569
8. Cyclodextrins as multifunctional tools for advanced biomaterials in tissue repair and regeneration.
   Lee YB, Kyun ML, Lee YJ, Shim HE, et al · · 2025 · cited 7× · PMID 40212783 · DOI 10.1016/j.bioactmat.2025.03.018