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

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00692250
Collaborator
(none)
14
Enrollment
1
Location
3
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

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
  • Drug: Colesevelam hydrochloride film-coated tablets (Cholestagel)
 Phase 1

Study Design

Study Type:
Interventional
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 :
Sep 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max)) [12 weeks]

Secondary Outcome Measures

  1. Safety [12]

  2. Tolerability [12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
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

Locations

Site City State Country Postal Code
1 University Medical Center Groningen- Biotech Center Groningen Netherlands

Sponsors and Collaborators

  • Genzyme, a Sanofi Company

Investigators

  • Study Director: Medical Monitor, Genzyme, a Sanofi Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00692250
Other Study ID Numbers:
  • CHOL00207
  • EudraCT 2007-003724-38
First Posted:
Jun 6, 2008
Last Update Posted:
May 5, 2015
Last Verified:
May 1, 2015
Keywords provided by , ,
Familial Hypercholesterolemia
Additional relevant MeSH terms:
Colesevelam Hydrochloride

Study Results

No Results Posted as of May 5, 2015