CYC102
A Multiple Dose, Multi-stage Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Colon Tissue Distribution of Cyclosporine Capsules (CyCol®) Compared to Intravenous Cyclosporine in Healthy Male Volunteers
Sponsor study identifier
interventional
48
0 countries
N/A
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
February 2015
Actual (reported)The aim of this Phase I, single centre, multi stage study is to evaluate the safety, tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 22, 2014
Actual (reported)May 5, 2014
Actual (reported)July 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)February 2015
Actual (reported)Pharmacokinetic variables for cyclosporine (in whole blood)
Area under the concentration-time curve (AUC) from; * time zero to the last non-zero concentration (AUC 0-t), * time zero extrapolated to infinity (AUC 0-inf), * maximum observed concentration (Cmax)
Day 1 and Day 7
Concentrations (ng/g) of cyclosporine and its metabolites (AM1, AM9, AM4N) in colonic mucosa
Concentrations (ng/g) of cyclosporine and its metabolites (AM1, AM9, AM4N)in colonic mucosal tissue
Day 2 or Day 7
Safety and Tolerability of CyCol
Day 1 to Day 7
Amount of unchanged cyclosporine and its metabolites excreted in faeces
Day 1 through Day 7
Sandimmun® IV 2mg/kg as a 24 hour infusion (2mg/kg/day)
CyCol®: 75 mg OD \& BID for 7 days
CyCol®: 37.5 mg OD or BID for 7 days
2 mg/kg IV
Sigmoid Pharma
Sigmoid Pharma
48 participants (actual enrollment reported by the registry).
First Submitted
April 22, 2014
First Posted
May 5, 2014
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
CyCol®: 150 mg OD or BID for 7 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2015
Actual (reported)Study Completion
February 2015
Actual (reported)Last Updated
May 19, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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