Sulforadex in Healthy Human Males MAD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02055716|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : February 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Sulforadex Drug: alpha-cyclodextrin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||May 2014|
Placebo Comparator: alpha-cyclodextrin
A placebo comparator composed of the same acid resistant HPMC capsules filled with 300mg of alpha cyclodextrin
100mg or 300mg size 00 acid resistant HPMC capsules
Other Name: Stabilised sulforaphane
- 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.
- Area under the plasma concentration versus time curve (AUC) of sulforaphane [ Time Frame: time 0, 30 min 1 2 4 8 12 & 24 hrs post dose on days 1,2 & 7 ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055716
|Richmond Pharmacology Limited|
|London, United Kingdom, SW17 0RE|
|Principal Investigator:||Jörg Täubel, MD FFPM||Richmond Pharmacology Limited|