Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects

Chronic Kidney Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976572
• Other study ID #: MCI-196-E17
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2013
• Last updated: September 28, 2015
• Start date: October 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• colestilan

• candesartan

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd.	Leeds	Springfield House Hyde Street

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t of Candesartan	Area under the plasma concentration-time curve from time zero up to the last quantifiable time-poin	From pre-dpse to 48 hours post-dose	No
Primary	Cmax of Candesartan	Maximum observed plasma concentration	From pre-dpse to 48 hours post-dose	No
Secondary	Tmax		From pre-dose to 48 hours post-dose	No
Secondary	t1/2		From pre-dose to 48 hours post-dose	No