Clinical trial NCT00692250: A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Familial Hypercholesterolemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


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.

Primary outcomes:
measure: Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety
timeFrame: 12
measure: Tolerability
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen- Biotech Center
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: