- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01976572
Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
April 6, 2017 updated by: Mitsubishi Tanabe Pharma Corporation
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
The primary objective is to assess the effects of colestilan on the pharmacokinetic profile of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours after the first daily dose of colestilan administered at doses of 5 g three times daily compared to administration of candesartan cilexetil alone, in healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Springfield House Hyde Street
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Leeds, Springfield House Hyde Street, United Kingdom
- Covance Clinical Research Unit Ltd.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Able to provide written informed consent to participate in this study, after reading the participant information sheet and informed consent form (ICF), and after having the opportunity to discuss the study with the Investigator or designee.
- Caucasian male subjects aged 18 to 50 years inclusive.
- A body mass index (BMI) between 18.0 and 32.0 kg/m2, both inclusive.
- Healthy subjects, free from any clinically significant illness or disease as determined by their medical history, physical examination, electrocardiogram (ECG), vital signs, biochemistry, haematology, coagulation, urinalysis, and serology.
- Male subjects, and their partners, agree to use contraception throughout the study duration. Male subjects must use 1 barrier method of contraception and spermicide during the trial, and for 3 months after the last dose of study drug. Male subjects with female partners of child-bearing potential must also agree to use an additional highly effective method of contraception. They must use a condom, and their female partners must use an additional method of contraception (such as cap or diaphragm), unless the subject or his partner has been sterilised, in which case, male subjects must use a condom and spermicide.
Exclusion Criteria:
- Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration, as determined by the Investigator based on abnormal medical history, physical findings, or laboratory values at Screening or Baseline.
- Unable to swallow colestilan tablets, current and/or history of dysphagia.
- Current or any history of any of the following gastrointestinal (GI) diseases: intestinal obstruction, chronic or severe constipation, subileus, ileus, intestinal stenosis, intestinal diverticulosis and/or diverticulitis, colitis, GI ulcers, recent major GI surgery, peritonitis, GI bleeding, gastritis, haemorrhoids, or any other severe GI disease.
- Current or any history of biliary obstruction, cholestasis, or severe hepatic impairment.
- Current or history of seizure disorders.
- Current or history of Vitamin K deficiency.
- Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator.
- Current or recent history (in the last 2 years) of abuse or addiction (tobacco, alcohol, drugs or substances), or weekly alcohol intake of more than 21 units, or a positive alcohol breath test or urine drug screen at Screening or Baseline. One unit is equivalent to a ½ pint (280 mL) of beer, 1 measure (25 mL) of spirits or 1 small glass (125 mL) of wine.
- Treatment with any drugs or herbal or dietary supplements known to be inhibitors of cytochrome P450 (CYP) 3A4, CYP2C9 or P-glycoprotein, 7 days before dosing and inducers of CYP3A4, CYP2C9, or P-glycoprotein 14 days before dosing.
- Treatment with H2 antagonist and/or proton pump inhibitors, during 4 weeks before dosing.
- Subjects with a history of hypotension or hyperkalaemia, or a postural drop of systolic blood pressure ≥20 mmHg at Screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Candesartan alone
Single dose of 16 mg candesartan was administered orally on Day 1.
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Active Comparator: T0hr
Colestilan was administered orally 5 g t.i.d (total dose 15 g/day) in the fed state immediately after meals from Day 3 to Day 24 and single dose of 16 mg candesartan was administered orally on Day 7, 13 and 19 at 1 of 3 dosing time-points relative to the first daily dose of 5 g colestilan t.i.d.
T-0 of 3 dosing time-points means the single dose of candesartan was administered at the same time relative to the first daily dose of colestilan.
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Other Names:
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Active Comparator: T-1hr
Colestilan was administered orally 5 g t.i.d (total dose 15 g/day) in the fed state immediately after meals from Day 3 to Day 24 and single dose of 16 mg candesartan was administered orally on Day 7, 13 and 19 at 1 of 3 dosing time-points relative to the first daily dose of 5 g colestilan t.i.d.
T-1 of 3 dosing time-points means the single dose of candesartan was administered at 1 hour before relative to the first daily dose of colestilan.
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Other Names:
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Active Comparator: T+3hr
Colestilan was administered orally 5 g t.i.d (total dose 15 g/day) in the fed state immediately after meals from Day 3 to Day 24 and single dose of 16 mg candesartan was administered orally on Day 7, 13 and 19 at 1 of 3 dosing time-points relative to the first daily dose of 5 g colestilan t.i.d.
T+3 of 3 dosing time-points means the single dose of candesartan was administered at 3 hour after relative to the first daily dose of colestilan.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-t of Candesartan
Time Frame: 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose
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Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point
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0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose
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Cmax of Candesartan
Time Frame: 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose
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Maximum observed plasma concentration
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0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax
Time Frame: 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose
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Time of maximum observed plasma concentration
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0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose
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T1/2
Time Frame: 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose
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Apparent plasma terminal elimination half-life
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0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jim Bush, Dr, Covance
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
October 30, 2013
First Submitted That Met QC Criteria
November 5, 2013
First Posted (Estimate)
November 6, 2013
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
April 6, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Urologic Diseases
- Renal Insufficiency
- Phosphorus Metabolism Disorders
- Kidney Diseases
- Renal Insufficiency, Chronic
- Hyperphosphatemia
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Candesartan
Other Study ID Numbers
- MCI-196-E17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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