Not yet recruitingNCT07867171Updated Oct 9, 2026

A Study to Investigate the Effects of Moderate or Severe Renal Impairment (RI) on Velzatinib

A Phase 1 interventional study of Velzatinib in Healthy Participants and Gastrointestinal Neoplasms, sponsored by GlaxoSmithKline. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Updated Oct 9, 2026Newly registeredGo to Updates ↓

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Non-randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

This study evaluates the effect of moderate and severe renal impairment on the pharmacokinetics (PK) of velzatinib compared with normal renal function.

Conditions studied

Healthy Participants
Gastrointestinal Neoplasms

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Keywords

Healthy participants
Renal Impairment
Pharmacokinetics
Velzatinib

In context

Gastrointestinal Neoplasms

795 studies on the registry are indexed under Gastrointestinal Neoplasms; 235 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 580 interventional studies indexed under Gastrointestinal Neoplasms.

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Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
Participants with Moderate Renal Impairment receiving velzatinib
Drug: Velzatinib
Experimental
Participants with Severe Renal Impairment receiving velzatinib
Drug: Velzatinib
Active comparator
Participants with Normal Renal Function receiving velzatinib
Drug: Velzatinib

Interventions

DrugVelzatinib
Velzatinib will be administered.
Also known as: GSK6042981/IDRX-42

What researchers measure

Primary outcomes

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

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
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).
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

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Data sharing details ↗ · www.gsk-studyregister.com

No publications or documents are linked to this record.

Updates

1 registry update since Sep 25, 2026

Registered

First appeared on the registry. No changes since

Oct 9, 2026

Show all 1 update

Oct 9, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07867171
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Oct 9, 2026
Start date: Oct 23, 2026 (estimated)
Primary completion: Sep 9, 2027 (estimated)
Completion: Sep 9, 2027 (estimated)
Last update: Oct 9, 2026

Study contacts

US GSK Clinical Trials Call Center

Contact

GSKClinicalSupportHD@gsk.com

877-379-3718

EU GSK Clinical Trials Call Center

Contact

GSKClinicalSupportHD@gsk.com

+44 (0) 20 89904466

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: IDRX-42

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