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

NCT00692250 | Completed Phase 1

• 2 other identifiers: CHOL00207EudraCT 2007-003724-38
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))

  12 weeks

Secondary Outcomes (2)

• Safety

  12

• Tolerability

  12 Weeks

Interventions

Colesevelam hydrochloride film-coated tablets (Cholestagel) DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

University Medical Center Groningen- Biotech Center

Groningen, Netherlands

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 6, 2008
• Study Start: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

NL (1)