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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692250
First Posted: June 6, 2008
Last Update Posted: May 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

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
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.
  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


Locations
Netherlands
University Medical Center Groningen- Biotech Center
Groningen, Netherlands
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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 Submitted: June 3, 2008
First Posted: June 6, 2008
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Sanofi:
Familial Hypercholesterolemia

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
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
Antimetabolites
Lipid Regulating Agents