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To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male volunteers over 7 days with qd or bid dosing
This study will be conducted in a randomised, double-blind, placebo-controlled design with multiple ascending doses of Sulforadex® administered qd [once daily] or bid [twice daily]) to healthy male subjects between 18 to 45 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alpha-cyclodextrin | Placebo Comparator | A placebo comparator composed of the same acid resistant HPMC capsules filled with 300mg of alpha cyclodextrin |
|
| Sulforadex | Experimental | 100mg or 300mg size 00 acid resistant HPMC capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforadex | Drug |
|
| |
| alpha-cyclodextrin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of sulforaphane | Plasma sulforaphane concentrations will be measured by LCMS/MS assay. • Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t). | time 0, 30 min 1 2 4 8 12 & 24 hrs post dose on days 1,2 & 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jörg Täubel, MD FFPM | Richmond Pharmacology Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Limited | London | SW17 0RE | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C032613 | alpha-cyclodextrin |
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| Drug |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |