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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Colesevelam hydrochloride film-coated tablets (Cholestagel)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Colesevelam hydrochloride film-coated tablets (Cholestagel)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max)) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 12 | 
| Tolerability |  | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Familial Hypercholesterolemia