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A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00692250
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : May 5, 2015
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Colesevelam hydrochloride film-coated tablets (Cholestagel) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : September 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max)) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 12 ]
  2. Tolerability [ Time Frame: 12 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692250

University Medical Center Groningen- Biotech Center
Groningen, Netherlands
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00692250     History of Changes
Other Study ID Numbers: CHOL00207
EudraCT 2007-003724-38
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Sanofi:
Familial Hypercholesterolemia

Additional relevant MeSH terms:
Colesevelam Hydrochloride
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents