NCT02130414

PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sigmoid Pharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is an open label, multiple-dose, multi-stage pharmacokinetic (PK) study. A maximum of 40 healthy adult male volunteers aged between 18 and 55 years will be enrolled at a single clinical research unit. For each CyCol® group dosing will last 7 days, whilst the Sandimmun® IV group will have a single dose over 24 hours. Single dose pharmacokinetics of different doses of CyCol® will be compared to IV Sandimmun®. In addition colonic tissue concentrations will be compared after multiple doses of CyCol® to a single IV dose of Sandimmun®. Concentrations of unchanged cyclosporine and it's metabolites in the faeces will also be explored. Stage 1 of the study will investigate the 75mg dose (OD and BID) of CyCol® and IV Sandimmun®. Then dependent on results Stages 2 and 3 will investigate either lower (37.5mg) or higher (150mg) dose levels. The dosing regimens chosen for Stages 2 and 3 will be based upon safety and tolerability, systemic exposure and colonic mucosa tissue concentrations observed at other doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sandimmun® IV	2 mg/kg IV
DRUG	CyCol® capsules	37.5 mg CyCol® capsules

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2014-05-05
• Last updated: 2015-05-19