Colestilan and Candesartan Cilexetil Drug Drug Interaction Study
Research type
Research Study
Full title
A Randomised, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Oral Doses of Candesartan Cilexetil in Healthy Subjects
IRAS ID
136231
Contact name
Jim Bush
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma Corporation
Eudract number
2013-001351-12
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
The principal mode of action of colestilan (MCI 196) is to absorb bile acids (steroid acids that aid in fat absorption and modulate cholesterol levels) and phosphorus in the gastrointestinal (GI) tract. The absorption of bile acids is the mechanism responsible for its cholesterol lowering activity. The absorption of phosphorus in the GI tract enables colestilan (MCI 196) to be considered as a potential agent for the treatment of hyperphosphatemia (abnormally elevated levels of phosphate)in chronic kidney disease patients with hyperphosphatemia.
The current drug- drug interaction study explores the potential binding of colestilan in the GI tract which may delay or reduce the absorption of other oral medications. At the request of the European Medicines Agency (EMA), this drug drug interaction study will further evaluate the Summary of Product Characteristics recommendation relating to the time intervals of 1 hour before, or 3 hours after in regards to the dosing of other medications, in this case candesartan cilexetil, which binds 100% to colestilan.
In the Run In Period, subjects will receive a single oral dose of candesartan cilexetil (16 mg) on Day 1.
In the Combination Treatment Periods 1 to 3, subjects will receive colestilan (5 g) three times daily (total dose 15 g/day) from Day 3 to Day 24. On Day 7, 13, and 19, subjects will also receive single doses of candesartan cilexetil (16 mg) at the same time as (T0), 1 hour before (T-1), and 3 hours after (T+3) respective to the first daily dose of colestilan, depending upon the treatment regimen.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0411
Date of REC Opinion
3 Oct 2013
REC opinion
Further Information Favourable Opinion