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

NCT ID: NCT00692250

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-12-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

Colesevelam hydrochloride film-coated tablets (Cholestagel)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme Corporation

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

University Medical Center Groningen- Biotech Center

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

EudraCT 2007-003724-38

Identifier Type: -

Identifier Source: secondary_id

CHOL00207

Identifier Type: -

Identifier Source: org_study_id