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Kidney impairment may change how MK-8527 works in the body
NCT ID NCT06295796
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 study looked at how the drug MK-8527 is processed in people with moderate or severe kidney impairment compared to healthy volunteers. Eighteen participants received a single oral dose, and researchers measured drug levels in the blood over time. The goal was to understand how kidney function affects the drug's behavior, not to test any treatment effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MK-8527
- What this could lead to
- If successful, this study could help doctors determine the right dose of MK-8527 for patients with kidney problems.
- What could go wrong
- This is a very early, small study (18 participants) focused on drug levels, not on treating any disease. It does not test whether MK-8527 works for any condition.
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.
- Started
-
Jun 2024
- Finished
-
Jan 2025
- 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 75 years
- Sex
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Anyone
- 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: The main inclusion criteria include but are not limited to the following: Moderate and Severe RI * With the exception of RI, is in sufficient health for study participation. * Has stable renal function. Healthy * Matches mean age to participants with moderate and severe RI. * Has normal renal function. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: All participants * History of cancer (malignancy). * Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV). * Had a major surgery or lost significant volume of blood within 56 days prior to dosing. * Donated plasma within 7 days prior to dosing. Moderate and Severe RI * Failed renal transplant or had a nephrectomy. * End stage renal disease requiring dialysis. * Any significant arrhythmia or conduction abnormality. * Has non-sustained or sustained ventricular tachycardia.
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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
-
Research by Design ( Site 0001)
Chicago, Illinois, 60643, United States
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