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

NCT02130414 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-05-19

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Sandimmun® IV

2 mg/kg IV

DRUG

CyCol® capsules

37.5 mg CyCol® capsules

Sponsors & Collaborators

  • Sigmoid Pharma

    lead INDUSTRY

Principal Investigators

  • Sigmoid Pharma · Sigmoid Pharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-01-31
Completion
2015-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02130414 on ClinicalTrials.gov