A Study to Investigate the Effects of Moderate or Severe Renal Impairment (RI) on Velzatinib
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGlaxoSmithKline
About this trial
This study evaluates the effect of moderate and severe renal impairment on the pharmacokinetics (PK) of velzatinib compared with normal renal function.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Velzatinib
DrugVelzatinib will be administered.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Participants with Moderate Renal Impairment receiving velzatinibExperimental treatment 1 intervention
Group B: Participants with Severe Renal Impairment receiving velzatinibExperimental treatment 1 intervention
Group C: Participants with Normal Renal Function receiving velzatinibActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximum observed plasma concentration (Cmax)
Time frame
Up to 936 hours2
Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])
Time frame
Up to 936 hours3
Maximum plasma unbound concentration (Cmax,u)
Time frame
Up to 936 hours4
Area under the unbound plasma concentration-time curve extrapolated to infinity (AUC[0-inf],u)
Time frame
Up to 936 hoursSecondary outcomes
1
Time to maximum observed plasma concentration (Tmax)
Time frame
Up to 936 hours2
Area under the concentration-time curve from time zero to 48 hours post-dose administration (AUC[0-48])
Time frame
Up to 48 hours3
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-last])
Time frame
Up to 936 hours4
Terminal elimination rate constant
Time frame
Up to 936 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: