Healthy ParticipantsPhase 1NCT07867171
A Study to Investigate the Effects of Moderate or Severe Renal Impairment (RI) on Velzatinib
A Phase 1 study testing Velzatinib in people with Healthy Participants and Gastrointestinal Neoplasms, run by GlaxoSmithKline.
Trial summary
This study evaluates the effect of moderate and severe renal impairment on the pharmacokinetics (PK) of velzatinib compared with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Gastrointestinal Neoplasms
- What is being tested?
- Velzatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2026to 9 Sep 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
- Participants are 18 to 80 years of age, inclusive, at the time of signing the Informed consent form (ICF).
- Participants has stable renal function that can be classified into 1 of 3 groups based on estimated GFR at screening.
- Participants with moderate/severe RI may be taking medications, which in the opinion of the investigator, are believed to be therapeutic but do not affect study drug Absorption, distribution, metabolism, excretion (ADME).
- The participant has no clinically significant and unstable cardiovascular (CV) or endocrine findings, except as expected by their pre-existing renal condition in the investigator's opinion (participants with renal impairment).
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants with chronic disorders such as hypertension and diabetes mellitus can be enrolled, provided those disorders are stable and adequately controlled, but otherwise participants should be considered healthy for their age (participants with normal renal function).
Who cannot join
- Participants has a history or evidence of clinically significant hematologic, dermatologic, neurologic, pulmonary, immunologic or atopic (except seasonal allergies), or endocrine disease, or psychiatric disorder (such as psychosis, delusions, or schizophrenia), or other abnormality, that may impact the ability of the participant to participate or potentially confound the study results, or that, in the investigator's opinion, makes the participant unsuitable for the study.
- Semi-supine blood pressure (BP) outside the ranges of 100 to 160 millimeters of mercury (mmHg) for systolic BP and 50 to 95 mmHg for diastolic BP (BP to be measured in triplicate), or a semi-supine pulse rate outside the range of 45 to 100 beats per minute (bpm).
- Participants has orthostatic hypotension such that there is a decrease in systolic BP of greater than equal to (>=)20 mmHg or in diastolic BP of >=10 mmHg, or pulse rate increase >=30 bpm.
- Has current or chronic history of liver disease (including acute or chronic hepatitis B or hepatitis C) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) (participants with renal impairment).
- Has nephrotic syndrome.
- Has a clinically significant elevation in serum potassium, that in the opinion of the investigator and medical monitor will interfere with the study or introduce additional safety risk to the participant.
Show all 10Show fewer
- Has a serum sodium level <=125 milliequivalents per Liters (mEq/L) (participants with renal impairment).
- Has a functioning, likely or planned renal transplant (participants with renal impairment).
- On dialysis or considered likely to require dialysis during the study (participants with renal impairment).
- Has clinically significant cardiac disease, including second- or third-degree atrioventricular block, clinically significant tachyarrhythmias, or atrial fibrillation/flutter.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of Velzatinib in Participants With Moderate or Severe Renal Impairment Compared to Healthy Participants
This study evaluates the effect of moderate and severe renal impairment on the pharmacokinetics (PK) of velzatinib compared with normal renal function.
- Conditions
- Healthy Participants, Gastrointestinal Neoplasms
- Being tested
- Velzatinib
- Keywords
- Healthy participants, Renal Impairment, Pharmacokinetics, Velzatinib
- Medical subject headings
- Gastrointestinal Neoplasms, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelzatinibDrug
Also called GSK6042981/IDRX-42
Velzatinib will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Moderate Renal Impairment receiving velzatinib | Experimental | Not described Receives: Drug: Velzatinib |
| Participants with Severe Renal Impairment receiving velzatinib | Experimental | Not described Receives: Drug: Velzatinib |
| Participants with Normal Renal Function receiving velzatinib | Active comparator | Not described Receives: Drug: Velzatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 936 hours
Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])
Measured: Up to 936 hours
Maximum plasma unbound concentration (Cmax,u)
Measured: Up to 936 hours
Area under the unbound plasma concentration-time curve extrapolated to infinity (AUC[0-inf],u)
Measured: Up to 936 hours
Renal clearance (CLr)
Measured: Up to Day 3
Secondary outcomes (12)
Time to maximum observed plasma concentration (Tmax)
Measured: Up to 936 hours
Area under the concentration-time curve from time zero to 48 hours post-dose administration (AUC[0-48])
Measured: Up to 48 hours
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-last])
Measured: Up to 936 hours
Terminal elimination rate constant
Measured: Up to 936 hours
Apparent terminal phase half-life (t1/2)
Measured: Up to 936 hours
Apparent clearance (CL/F)
Measured: Up to 936 hours
Apparent volume of distribution (Vz/F)
Measured: Up to 936 hours
Total amount of drug excreted into urine
Measured: Up to Day 3
Percentage of the total dose of drug excreted into urine
Measured: Up to Day 3
Regression coefficient between pharmacokinetic parameters and measures of renal function
The relationship between PK parameters and measures of renal function will be evaluated using regression analyses. Regression coefficients will be summarized to describe the direction and magnitude of the relationship. A positive regression coefficient indicates that an increase in the renal function parameter is associated with an increase in the PK parameter, whereas a negative regression coefficient indicates that an increase in the renal function parameter is associated with a decrease in the PK parameter. A regression coefficient close to zero suggests little or no linear relationship between the renal-function measure and the PK parameter. Unit of measure: unitless (will be reported as a regression coefficient).
Measured: Up to 936 hours
Number of participants with adverse event (AEs) and serious adverse event (SAEs) by severity
Measured: Up to Day 40
Number of participants with clinically important changes in vital signs, electrocardiograms (ECG), physical examination and clinical laboratory parameters
Measured: Up to Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start23 Oct 2026 (estimated)
- Primary completion9 Sep 2027 (estimated)
- Study completion9 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867171
- Sponsor's protocol ID
- 301043
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of Velzatinib in Participants With Moderate or Severe Renal Impairment Compared to Healthy Participants
- ClinicalTrials.gov ID
- NCT07867171
- Acronym / sponsor ID
- 301043
- Conditions
- Healthy Participants, Gastrointestinal Neoplasms
- Keywords
- Healthy participants, Renal Impairment, Pharmacokinetics, Velzatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 9 Sep 2027 (estimated)
- Study completion
- 9 Sep 2027 (estimated)
- First posted
- 9 Oct 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.
This study evaluates the effect of moderate and severe renal impairment on the pharmacokinetics (PK) of velzatinib compared with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with Moderate Renal Impairment receiving velzatinib | Experimental | Drug: Velzatinib |
| Participants with Severe Renal Impairment receiving velzatinib | Experimental | Drug: Velzatinib |
| Participants with Normal Renal Function receiving velzatinib | Active comparator | Drug: Velzatinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants are 18 to 80 years of age, inclusive, at the time of signing the Informed consent form (ICF).
- Participants has stable renal function that can be classified into 1 of 3 groups based on estimated GFR at screening.
- Participants with moderate/severe RI may be taking medications, which in the opinion of the investigator, are believed to be therapeutic but do not affect study drug Absorption, distribution, metabolism, excretion (ADME).
- The participant has no clinically significant and unstable cardiovascular (CV) or endocrine findings, except as expected by their pre-existing renal condition in the investigator's opinion (participants with renal impairment).
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants with chronic disorders such as hypertension and diabetes mellitus can be enrolled, provided those disorders are stable and adequately controlled, but otherwise participants should be considered healthy for their age (participants with normal renal function).
Key exclusion criteria (10 listed)
- Participants has a history or evidence of clinically significant hematologic, dermatologic, neurologic, pulmonary, immunologic or atopic (except seasonal allergies), or endocrine disease, or psychiatric disorder (such as psychosis, delusions, or schizophrenia), or other abnormality, that may impact the ability of the participant to participate or potentially confound the study results, or that, in the investigator's opinion, makes the participant unsuitable for the study.
- Semi-supine blood pressure (BP) outside the ranges of 100 to 160 millimeters of mercury (mmHg) for systolic BP and 50 to 95 mmHg for diastolic BP (BP to be measured in triplicate), or a semi-supine pulse rate outside the range of 45 to 100 beats per minute (bpm).
- Participants has orthostatic hypotension such that there is a decrease in systolic BP of greater than equal to (>=)20 mmHg or in diastolic BP of >=10 mmHg, or pulse rate increase >=30 bpm.
- Has current or chronic history of liver disease (including acute or chronic hepatitis B or hepatitis C) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) (participants with renal impairment).
- Has nephrotic syndrome.
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 |
|---|---|---|
| VelzatinibAlso: GSK6042981/IDRX-42Velzatinib will be administered. | Drug | Participants with Moderate Renal Impairment receiving velzatinib, Participants with Normal Renal Function receiving velzatinib, Participants with Severe Renal Impairment receiving velzatinib |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 936 hours
Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])
Time frame: Up to 936 hours
Maximum plasma unbound concentration (Cmax,u)
Time frame: Up to 936 hours
Area under the unbound plasma concentration-time curve extrapolated to infinity (AUC[0-inf],u)
Time frame: Up to 936 hours
Renal clearance (CLr)
Time frame: Up to Day 3
12 secondary outcomes
Time to maximum observed plasma concentration (Tmax)
Time frame: Up to 936 hours
Area under the concentration-time curve from time zero to 48 hours post-dose administration (AUC[0-48])
Time frame: Up to 48 hours
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-last])
Time frame: Up to 936 hours
Terminal elimination rate constant
Time frame: Up to 936 hours
Apparent terminal phase half-life (t1/2)
Time frame: Up to 936 hours
Apparent clearance (CL/F)
Time frame: Up to 936 hours
Apparent volume of distribution (Vz/F)
Time frame: Up to 936 hours
Total amount of drug excreted into urine
Time frame: Up to Day 3
Percentage of the total dose of drug excreted into urine
Time frame: Up to Day 3
Regression coefficient between pharmacokinetic parameters and measures of renal function
Time frame: Up to 936 hours
Number of participants with adverse event (AEs) and serious adverse event (SAEs) by severity
Time frame: Up to Day 40
Number of participants with clinically important changes in vital signs, electrocardiograms (ECG), physical examination and clinical laboratory parameters
Time frame: Up to Day 40
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 9 Oct 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Velzatinib in people with Healthy Participants and Gastrointestinal Neoplasms, run by GlaxoSmithKline.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Up to 936 hours). The study lists 5 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 9 Oct 2026.