Status:
COMPLETED
A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00692250
Start Date
September 1 2007
End Date
December 1 2007
Last Update
May 5 2015
Active Locations (1)
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1
University Medical Center Groningen- Biotech Center
Groningen, Netherlands