Last updated: 10/01/2026 06:02:45

A study to investigate the effects of impaired hepatic function on velzatinib

GSK study ID
301039
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 Hepatic Impairment Compared to Healthy Participants
Trial description: This study evaluates the pharmacokinetics (PK), safety, and tolerability of velzatinib in participants with mild, moderate, and severe hepatic impairment (HI) and participants with normal hepatic function.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Maximum plasma concentration (Cmax)

Timeframe: Up to 936 hours

Area under the plasma concentration-time curve 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

Secondary outcomes:

Time to maximum observed plasma drug concentration (Tmax)

Timeframe: Up to 936 hours

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

Timeframe: Up to 48 hours

Area under the plasma drug concentration-time curve from time 0 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

Regression coefficient Between Pharmacokinetic Parameters and Measures of Hepatic Function

Timeframe: Up to 936 hours

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

Timeframe: Up to 40 days

Number of participants with clinically significant changes in clinical laboratory parameters, physical examinations, Electrocardiogram (ECG) and vital signs

Timeframe: Up to 40 days

Interventions:
Drug: Velzatinib
Enrollment:
40
Primary completion date:
2028-25-04
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)
November 2026 to April 2028
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
Yes
  • Participant is 18 to 80 years of age, inclusive, at the time of signing the Informed consent form (ICF).
  • Participant has stable hepatic function that can be classified into 1 of 4 groups according to the Child-Pugh and National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG) classification.
  • Participant 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 140 millimeters of mercury (mmHg) for systolic BP and 50 to 90 mmHg for diastolic BP (BP to be measured in triplicate), or a semi-supine pulse rate outside the range of 45 to 90 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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