Timing matters: study tests best way to take kidney and blood pressure meds together
NCT ID NCT01976572
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 trial looked at how colestilan, a drug for high phosphate levels in kidney disease, affects the body's processing of candesartan, a blood pressure medication. Eighteen healthy men took candesartan alone or with colestilan at different times. The goal was to see if colestilan changes candesartan levels in the blood, which could help doctors recommend the best dosing schedule for patients who need both drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- colestilan and candesartan
- What this could lead to
- If successful, this could help doctors decide the best timing for taking colestilan and candesartan together to avoid drug interactions in people with kidney disease.
- What could go wrong
- This was a small, early-stage study in healthy volunteers, not patients. Results may not directly apply to people with kidney disease or other health conditions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
18 people
The number who actually took part.
- Start date
-
Oct 2013
- Finished
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Jan 2014
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
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Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Covance Clinical Research Unit Ltd.
Leeds, Springfield House Hyde Street, United Kingdom
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