Can a damaged kidney change how a drug works?
NCT ID NCT07797322
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests how the drug PKN605 moves through the body in people with moderate or severe kidney impairment compared to healthy volunteers. Researchers give a single oral dose and measure drug levels in the blood over time. The goal is to see if reduced kidney function increases drug exposure, which would guide dosing in future studies. Safety is also monitored throughout.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PKN605, an oral tablet taken on an empty stomach
- What this could lead to
- If it works, this could guide safe dosing of PKN605 for people with kidney impairment in future trials.
- What could go wrong
- This is an early, small study focused on drug levels, not on treating a disease. Results may not predict how the drug works in larger patient groups.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- 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
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18 to 80 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.
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: All participants (Group 1, 2 \& 3) * Male and female participants 18 to 80 years of age (inclusive). * Weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 42.0 kg/m2, inclusive, at Screening. Participants with moderate and severe RI (Group 1 \& 2) * Have impaired renal function as determined by the mean eGFR calculated using the CKD EPI Creatinine - Cystatin C equation (2021) (refer to Section 8.5.1 for equation), and fall into one of the following groups: * Group 1: moderate RI; eGFR 30 to 60 mL/min, inclusive. * Group 2: severe RI; eGFR \<30 mL/min, not requiring dialysis. * \*The mean eGFR will be calculated from 2 values: one obtained at Screening and a second obtained at least 72 hours later, either at Screening or at the Baseline visit. The mean of these 2 values will be used to assign the renal impairment group. * Have stable renal function with no clinically significant change (no change ≥25% from Screening 1 to Screening 2 or Baseline value) in renal status prior to first dosing of study treatment as determined by the Investigator and is not currently or has not been previously on hemodialysis for at least 1 year. Healthy control participants (Group 3) * Each healthy participant must match the age (±10 years), body weight (±15%), and sex of an individual participant in Group 1 and/or Group 2. * Has normal renal function with eGFR ≥90 mL/min, determined using the CKD-EPI Creatinine - Cystatin C equation (2021) at Screening. Exclusion Criteria: All participants (Group 1, 2 \& 3) * Women of childbearing potential (as defined in the protocol) need to use an effective contraception method during the course of this trial. * History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants such as: * Clinically significant ECG abnormalities that, in the opinion of the Investigator, would place the participant at increased risk. * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular block without a pacemaker. * History of long QT syndrome or known family history of ventricular arrhythmia or sudden cardiac death. * QT interval corrected by Fridericia's formula (QTcF) \>450 milliseconds (ms) for males and \>460 ms for females, unless considered not clinically significant and not associated with increased arrhythmic risk by the Investigator, with appropriate safety oversight; QTcF must not exceed 470 ms in males and 480 ms in females. * Use of agents known to prolong the QT interval unless they can be discontinued for the duration of study. * Initiation or dose adjustment within \<4 weeks of screening of medications known to cause acute changes in eGFR (e.g., angiotensin-converting-enzyme \[ACE\] inhibitors, angiotensin II receptor blockers \[ARBs\], sodium/glucose cotransporter 2 \[SGLT2\] inhibitors, diuretics, nonsteroidal anti-inflammatory drugs \[NSAIDs\]). Note: NSAIDs are excluded for use in participants with moderate and severe renal impairment (refer to Exclusion criterion 23). * Renal transplant recipients or has had a nephrectomy. Participants with moderate and severe RI (Group 1 \& 2) * Participants requiring dialysis. * Participants taking erythropoiesis-stimulating agents (ESAs) within the last 6 months of Screening and until end of study (EoS) visit. Healthy control participants (Group 3) • History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or blood urea nitrogen and/or urea values, or abnormal urinary constituents or eGFR \<90 mL/min in medical history or at Screening. Other protocol-defined inclusion/exclusion criteria may apply
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.