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

Healthy Clinical Trial

Official title:

A Phase I Open Label, Randomised, Single Dose, 2-way Crossover, 2-Sequence Pharmacokinetic Study on the Interaction of Colesevelam and Ciclosporin in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692250
• Other study ID #: CHOL00207
• Secondary ID: EudraCT 2007-003
• Status: Completed
• Phase: Phase 1
• First received: June 3, 2008
• Last updated: May 4, 2015
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: May 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Colesevelam hydrochloride film-coated tablets (Cholestagel)

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen- Biotech Center	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of Ciclosporin (AUC(0-t), AUC(8) and C(max))		12 weeks
Secondary	Safety		12
Secondary	Tolerability		12 Weeks