A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
This study has been completed.
Information provided by:
Genzyme, a Sanofi Company
First received: June 3, 2008
Last updated: May 4, 2010
Last verified: May 2010
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.
Drug: Colesevelam hydrochloride film-coated tablets (Cholestagel)
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
||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
Primary Outcome Measures:
- Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max)) [ Time Frame: 12 weeks ]
Secondary Outcome Measures:
- Safety [ Time Frame: 12 ]
- Tolerability [ Time Frame: 12 Weeks ]
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic, gastrointestinal (inclusive of dysphagia, swallowing disorders, severe gastrointestinal mortility 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692250
|University Medical Center Groningen- Biotech Center
|Groningen, Netherlands |
Genzyme, a Sanofi Company
||Genzyme, a Sanofi Company
No publications provided
||Medical Monitor, Genzyme Corporation
History of Changes
|Other Study ID Numbers:
||CHOL00207, EudraCT 2007-003724-38
|Study First Received:
||June 3, 2008
||May 4, 2010
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Keywords provided by Genzyme, a Sanofi Company:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Lipid Regulating Agents