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A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
This study has been completed.
Sponsored by: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00692250
  Purpose

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


Condition Intervention Phase
Familial Hypercholesterolemia
Drug: Colesevelam hydrochloride film-coated tablets (Cholestagel)
Phase I

Genetics Home Reference related topics: cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency
MedlinePlus related topics: Cholesterol
Drug Information available for: Cyclosporin Cyclosporine Colesevelam GT31-104
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
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

Further study details as provided by Genzyme:

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 ]

Enrollment: 14
Study Start Date: September 2007
Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692250

Locations
Netherlands
University Medical Center Groningen- Biotech Center
Groningen, Netherlands
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Genzyme Corporation ( Medical Monitor )
Study ID Numbers: CHOL00207, EudraCT 2007-003724-38
Study First Received: June 3, 2008
Last Updated: June 5, 2008
ClinicalTrials.gov Identifier: NCT00692250  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:
Lipid Metabolism, Inborn Errors
Hypercholesterolemia, autosomal dominant
Colesevelam
Cyclosporine
Hyperlipidemias
Metabolic Diseases
Hyperlipoproteinemia Type II
Healthy
Cyclosporins
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic disorder
Hypercholesterolemia
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Anticholesteremic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009