Kidney function affects how drug MCI-186 moves through body
NCT ID NCT03289208
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study looked at how the drug MCI-186 is handled by the body in people with mild or moderate kidney impairment compared to those with normal kidneys. Thirty adults received a single dose of the drug, and researchers measured its levels in the blood. The goal was to understand if kidney function changes how the drug is processed, which helps guide proper dosing.
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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
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30 people
The number who actually took part.
- Started
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Oct 2016
- Finished
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Apr 2018
- Lead sponsor
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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
-
20 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: All subjects * Able to provide written informed consent to participate in this study after reading the ICF * Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements * A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2 Renal impaired subjects (in addition) * Subjects with mild renal impairment defined as eGFR 60-89 mL/min/1.73m2 and subjects with moderate renal impairment defined as eGFR 30-59 mL/min/1.73m2 * Chronic and stable renal impairment Healthy subjects (in addition) * Subject with normal renal function defined as eGFR≥90 mL/min/1.73m2 * Good health and free from clinically significant illness or disease Exclusion Criteria: All subjects * Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance * Subjects were previously administered MCI-186 * Positive urine drug screen (if not due to concomitant medication) or alcohol test * History of alcohol abuse or drug abuse * Presence of active infection requiring antibiotics * Positive test for human immunodeficiency virus (HIV) antigen/antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb) Renal impairment subject (in addition) * Acute renal failure * History of renal transplantation * Aspartate aminotransferase (AST) activity, or an alanine aminotransferase (ALT) activity of at least 3 times the upper limit of normal (ULN) range * Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)\>180 mmHg and/or diastolic blood pressure (DBP)\>110 mmHg * Start of any new medication or new any changes to a current dosage Healthy subject (in addition) * History or presence of any renal disease * Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)\>160 mmHg and/or diastolic blood pressure (DBP)\>100 mmHg
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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
-
Investigational site
Tokyo, Japan
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Other studies related to the condition(s) this trial covers.
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