Last updated: 10/01/2026 06:11:28

A study to investigate the effects of moderate or severe renal impairment (RI) on velzatinib

GSK study ID
301043
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: This study evaluates the effect of moderate and severe renal impairment on the pharmacokinetics (PK) of velzatinib compared with normal renal function.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Maximum observed plasma concentration (Cmax)

Timeframe: Up to 936 hours

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

Timeframe: Up to 936 hours

Maximum plasma unbound concentration (Cmax,u)

Timeframe: Up to 936 hours

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

Timeframe: Up to 936 hours

Renal clearance (CLr)

Timeframe: Up to Day 3

Secondary outcomes:

Time to maximum observed plasma concentration (Tmax)

Timeframe: Up to 936 hours

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

Timeframe: Up to 48 hours

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

Timeframe: Up to 936 hours

Terminal elimination rate constant

Timeframe: Up to 936 hours

Apparent terminal phase half-life (t1/2)

Timeframe: Up to 936 hours

Apparent clearance (CL/F)

Timeframe: Up to 936 hours

Apparent volume of distribution (Vz/F)

Timeframe: Up to 936 hours

Total amount of drug excreted into urine

Timeframe: Up to Day 3

Percentage of the total dose of drug excreted into urine

Timeframe: Up to Day 3

Regression coefficient between pharmacokinetic parameters and measures of renal function

Timeframe: Up to 936 hours

Number of participants with adverse event (AEs) and serious adverse event (SAEs) by severity

Timeframe: Up to Day 40

Number of participants with clinically important changes in vital signs, electrocardiograms (ECG), physical examination and clinical laboratory parameters

Timeframe: Up to Day 40

Interventions:
Drug: Velzatinib
Enrollment:
30
Primary completion date:
2027-09-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy participants, Gastrointestinal Neoplasms
Product
GSK6042981
Collaborators
Not applicable
Study date(s)
October 2026 to September 2027
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
Yes
  • 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 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).

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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