A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00692250
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study Completion: 2007-12
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

• Subject must have a body mass index (BMI) between 19 and 25 inclusive
• Medically healthy subjects with clinically normal laboratory profiles, physical exams, vital signs and ECGs.
• Give voluntary written informed consent to participate in the study

Exclusion Criteria

• History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic, gastrointestinal (inclusive of dysphagia, swallowing disorders, severe gastrointestinal motility disorders), endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease.
• In addition, history or presence of: Alcoholism or drug abuse within the past year; OR hypersensitivity or idiosyncratic reaction to ciclosporin or other immunosuppressive agents; OR Chronic infection
• Subjects who ere tested positive at screening for HIV, HBsAg or HCV
• Subjects who received injectable corticosteroids in the 12 weeks preceding the first dose.
• Subjects who are allergic to castor oil or corn oil
• Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing
• Subjects who have used any medications or substances known to be strong inhibitors of CYP3A enzymes within 10 days prior to the first dose.
• Subjects who have used any medications or substances known to be strong inducers of CYP3A enzymes within 28 days prior to the first dose.
• Subjects who have used antibiotics within 14 days prior to the first dose.
• Subjects who have used other medication (including over-the-counter products) vitamins and herbal products within 7 days prior to the first dose.
• Subjects who have used any live attenuated vaccine within 7 days prior to the first dose or are planning to use within 14 days after the end of the study.
• Subjects who, prior to informed consent, would have donated in excess of: 500mL of blood in 14 days;1500mL of blood in 180 days; OR 2500mL of blood in 1 year.
• Subjects who have participated in another clinical trial: within a period less or equal to 2 half live (t1/2) of the previous investigational product used OR within 60 days prior to first dose.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))	12 weeks

Secondary Outcome Measures

Name	Time	Method
Safety	12
Tolerability	12 Weeks

Trial Locations

Locations (1)

University Medical Center Groningen- Biotech Center; 🇳🇱 Groningen, Netherlands