Participants With Moderate and Severe Renal Impairment and Healthy ParticipantsPhase 1NCT07797322
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
A Phase 1 study testing PKN605 in people with Participants With Moderate and Severe Renal Impairment and Healthy Participants, run by Novartis Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Participants With Moderate and Severe Renal Impairment and Healthy Participants
- What is being tested?
- PKN605
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2026to 2 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United States3 sites, 3 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Dyal Garg, +1 305 355 5111, dgarg8838@aol.com
Richard A Preston
- Recruiting
Orlando Clinical Research Center Inc
Orlando, Florida, 32809
Cindy Brown, cbrown@ocrc.net
Thomas C Marbury
- Recruiting
Genesis Clinical Research
Tampa, Florida, 33614
Lauren Navarro, lnavarro@genesistrials.com
Jesus Navarro
About this study
Official title: A Phase 1, Single-dose, Open-label Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Healthy Participants With Normal Renal Function
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
Read the detailed description
This is a Phase 1, single-dose, open-label, non-randomized renal impairment study to assess the PK after a single administration of PKN605 in participants with moderate (Group 1) and severe (Group 2) renal impairment and matched healthy participants with normal renal function (Group 3).
- Being tested
- PKN605
- Keywords
- PKN605, renal impairment, PK, safety, tolerability
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PKN605Drug
PKN605 orally as a tablet under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | PKN605 in participants with moderate renal impairment Receives: Drug: PKN605 |
| Group 2 | Experimental | PKN605 in participants with severe renal impairment Receives: Drug: PKN605 |
| Group 3 | Experimental | PKN605 in healthy participants with normal renal function Receives: Drug: PKN605 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary plasma PK parameters: Cmax
Cmax: The maximum (peak) observed plasma concentration
Measured: Up to 5 days
Primary plasma PK parameters: AUClast
AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast)
Measured: Up to 5 days
Primary plasma PK parameters: AUCinf
AUCinf: The AUC from time zero to infinity
Measured: Up to 5 days
Secondary plasma PK parameters: Tmax
Tmax: The time to reach maximum (peak) plasma concentration
Measured: Up to 5 days
Secondary plasma PK parameters: AUC0-t
AUC0-t: The AUC from time zero to time t
Measured: Up to 5 days
Secondary plasma PK parameters: T1/2
T1/2: The elimination half-life associated with the terminal slope (λz) of a semi-logarithmic concentration-time curve (time)
Measured: Up to 5 days
Secondary plasma PK parameters: Tlast
Tlast: The last measurable concentration sampling time
Measured: Up to 5 days
Secondary plasma PK parameters: CL/F
CL/F: The apparent total body clearance of drug from the plasma
Measured: Up to 5 days
Secondary plasma PK parameters: Vz/F
Vz/F: The apparent volume of distribution during terminal phase (associated with λz)
Measured: Up to 5 days
Secondary outcomes (1)
Number of participants with Adverse Events (AEs)
Number of participants with Adverse Events (AEs), including abnormal vital signs, electrocardiograms (ECGs) and safety laboratory parameters
Measured: Up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants With Moderate and Severe Renal Impairment and Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797322
- Sponsor's protocol ID
- CPKN605A02104
- Status last verified
- Nov 2026
- First submitted
- 26 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-dose, Open-label Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Healthy Participants With Normal Renal Function
- ClinicalTrials.gov ID
- NCT07797322
- Acronym / sponsor ID
- CPKN605A02104
- Keywords
- PKN605, renal impairment, PK, safety, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 2 Mar 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
Detailed description
This is a Phase 1, single-dose, open-label, non-randomized renal impairment study to assess the PK after a single administration of PKN605 in participants with moderate (Group 1) and severe (Group 2) renal impairment and matched healthy participants with normal renal function (Group 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: PKN605PKN605 in participants with moderate renal impairment |
| Group 2 | Experimental | Drug: PKN605PKN605 in participants with severe renal impairment |
| Group 3 | Experimental | Drug: PKN605PKN605 in healthy participants with normal renal function |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PKN605PKN605 orally as a tablet under fasted conditions | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Primary plasma PK parameters: Cmax
Time frame: Up to 5 days
Cmax: The maximum (peak) observed plasma concentration
Primary plasma PK parameters: AUClast
Time frame: Up to 5 days
AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast)
Primary plasma PK parameters: AUCinf
Time frame: Up to 5 days
AUCinf: The AUC from time zero to infinity
Secondary plasma PK parameters: Tmax
Time frame: Up to 5 days
Tmax: The time to reach maximum (peak) plasma concentration
Secondary plasma PK parameters: AUC0-t
Time frame: Up to 5 days
AUC0-t: The AUC from time zero to time t
Secondary plasma PK parameters: T1/2
Time frame: Up to 5 days
T1/2: The elimination half-life associated with the terminal slope (λz) of a semi-logarithmic concentration-time curve (time)
Secondary plasma PK parameters: Tlast
Time frame: Up to 5 days
Tlast: The last measurable concentration sampling time
Secondary plasma PK parameters: CL/F
Time frame: Up to 5 days
CL/F: The apparent total body clearance of drug from the plasma
Secondary plasma PK parameters: Vz/F
Time frame: Up to 5 days
Vz/F: The apparent volume of distribution during terminal phase (associated with λz)
1 secondary outcome
Number of participants with Adverse Events (AEs)
Time frame: Up to 35 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PKN605 in people with Participants With Moderate and Severe Renal Impairment and Healthy Participants, run by Novartis Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary plasma PK parameters: Cmax (time frame: Up to 5 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.