Health TrialsbyHealthPanel

A Study to Investigate the Effects of Impaired Hepatic Function on Velzatinib

ConditionsHealthy ParticipantsGastrointestinal Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 stable hepatic function (i.e., no clinically significant change in status according to the investigator's clinical judgment within the preceding 14 days [e.g., no worsening of clinical signs of HI, or no worsening of total bilirubin or prothrombin by more than 50 percent]) and those needing treatment are on stable doses of medication.

Participants with HI may be taking medications, which in the opinion of the investigator, are believed to be therapeutic but do not affect study intervention absorption, distribution, metabolism, excretion (ADME).

Disqualifiers

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).

Participant has symptoms arising from orthostatic hypotension such that there is a decrease in systolic BP of greater than or equal to (>=) 20 mmHg or in diastolic BP of >=10 mmHg, or pulse rate increase >=30 bpm.

Participant has history of extrahepatic disorders possibly related to etiology of cirrhosis (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, uncontrolled hypertension) (for participants with hepatic impairment).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Velzatinib

    Drug

    Velzatinib will be administered

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Participants with mild hepatic impairment receiving VelzatinibExperimental treatment 1 intervention
Group B: Participants with moderate hepatic impairment receiving VelzatinibExperimental treatment 1 intervention
Group C: Participants with severe hepatic impairment receiving VelzatinibExperimental treatment 1 intervention
Group D: Participants with normal hepatic function receiving VelzatinibActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximum plasma concentration (Cmax)

Time frame
Up to 936 hours
2

Area under the plasma concentration-time curve extrapolated to infinity AUC(0-inf)

Time frame
Up to 936 hours
3

Maximum plasma unbound concentration (Cmax,u)

Time frame
Up to 936 hours
4

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

Time frame
Up to 936 hours

Secondary outcomes

1

Time to maximum observed plasma drug concentration (Tmax)

Time frame
Up to 936 hours
2

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

Time frame
Up to 48 hours
3

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

Time frame
Up to 936 hours
4

Terminal elimination rate constant

Time frame
Up to 936 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: