Healthy
Conditions
Keywords
Familial Hypercholesterolemia
Brief summary
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.
Interventions
DRUGColesevelam hydrochloride film-coated tablets (Cholestagel)
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max)) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety | 12 |
| Tolerability | 12 Weeks |
Countries
Netherlands
Outcome results
None listed