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

NCT07867171 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 301043
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Keywords

Healthy participants; Renal Impairment; Pharmacokinetics; Velzatinib

Outcome Measures

Primary Outcomes (5)

• Maximum observed plasma concentration (Cmax)

  Up to 936 hours

• Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])

  Up to 936 hours

• Maximum plasma unbound concentration (Cmax,u)

  Up to 936 hours

• Area under the unbound plasma concentration-time curve extrapolated to infinity (AUC[0-inf],u)

  Up to 936 hours

• Renal clearance (CLr)

  Up to Day 3

Secondary Outcomes (12)

• Time to maximum observed plasma concentration (Tmax)

  Up to 936 hours

• Area under the concentration-time curve from time zero to 48 hours post-dose administration (AUC[0-48])

  Up to 48 hours

• Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-last])

  Up to 936 hours

• Terminal elimination rate constant

  Up to 936 hours

• Apparent terminal phase half-life (t1/2)

  Up to 936 hours

Study Arms (3)

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

Interventions

Velzatinib DRUG

Velzatinib will be administered.

Also known as: GSK6042981/IDRX-42

Participants with Moderate Renal Impairment receiving velzatinib; Participants with Normal Renal Function receiving velzatinib; Participants with Severe Renal Impairment receiving velzatinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Renal Insufficiency

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 23, 2026
• Primary Completion (Estimated): September 9, 2027
• Study Completion (Estimated): September 9, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.