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A Phase 1 Randomized, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enteric-Coated Stabilized Sulforaphane (SFX-01) in Male Participants
Advances in Therapy
2025
42(1):216-232
Bibliography
- PubMed
- PMID 39520658
- PubMed Central
- PMC11782309
- Funding
- The study was funded by TheraCryf PLC (formerly Evgen Pharma PLC), which also funded medical-writing support and the journal's Rapid Service/Open Access fees.
- Competing interests
- Glen Clack was an employee of TheraCryf PLC and managing director of Alise Oncology Ltd, a shareholder of TheraCryf PLC. The sponsor also held contractual control over individual-participant-data access as described in the paper.
Study snapshot
| Design | Phase 1 randomized double-blind placebo-controlled dose-escalation trial |
|---|---|
| Model | Healthy adult men |
| Sample | 24 |
| Intervention | Enteric-coated SFX-01 at 300 mg once daily (46.2 mg sulforaphane), 300 mg twice daily or 600 mg once daily (92.4 mg sulforaphane), versus placebo |
| Duration | 7 days |
| Endpoints | Treatment-emergent adverse events; Tolerability; Sulforaphane pharmacokinetics; Cmax; Urinary sulforaphane metabolite excretion |
What the study showed, in plain terms
Key findings
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