Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAscentage Pharma Group Inc.
About this trial
This is a non-randomized, open-label, parallel, single-dose study to evaluate the pharmacokinetic profile of olverembatinib in participants with normal or impaired liver function.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The participant voluntarily joins the study, signs the Informed Consent Form, and demonstrates good compliance.
Body Mass Index (BMI) between 18 and 30 kg/m² (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.
The investigator judges the participant suitable to participate in this study based on physical examination, vital signs, laboratory tests, and 12-lead electrocardiogram (ECG) examination.
Female participants of childbearing potential must agree to use effective contraception during the study and for 3 months after the study ends; must have a negative serum pregnancy test within 7 days prior to study enrollment; and must not be breastfeeding. Male participants must agree to use effective contraception during the study and for 3 months after the study ends.
Disqualifiers
Drug-induced liver injury.
Any of the following conditions: history of liver transplantation; presence of acute or worsening liver injury due to any cause; liver failure; concurrent Grade 3/4 hepatic encephalopathy; active hepatocellular carcinoma lesions; severe esophageal or gastric varices or history of rupture and bleeding; severe/late-stage ascites or pleural effusion requiring paracentesis/thoracentesis and albumin supplementation; hepatorenal syndrome; or any other condition deemed by the investigator as unsuitable for study participation.
History of cholestasis, biliary tract infection, or other diseases affecting bile excretion within 3 months prior to screening.
Esophageal or gastric variceal bleeding due to portal hypertension within 3 months prior to screening, or history of portosystemic shunt surgery (including Transjugular Intrahepatic Portosystemic Shunt - TIPS) within 6 months prior to screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Olverembatinib 20mg
Drugorally after meal, single dose
Treatment groups
48 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Group 1: 6-8 participants with mild hepatic impairment.Experimental treatment 1 intervention
Group B: Group 2: 6-8 participants with normal hepatic function matched to Group 1Experimental treatment 1 intervention
Group C: Group 3: 6-8 participants with moderate hepatic impairmentExperimental treatment 1 intervention
Group D: Group 4: 6-8 participants with normal hepatic function matched to Group 3Experimental treatment 1 intervention
Group E: Group 5: 6-8 participants with severe hepatic impairmentExperimental treatment 1 intervention
Group F: Group 6: 6-8 participants with normal hepatic function matched to Group 5Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum observed plasma concentration C(max)
The C(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Time frame
Day 1 to Day 92
Time to C(max) [ t(max) ]
The t(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Time frame
Day 1 to Day 93
Apparent terminal elimination half-life (t½)
The t½ of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Time frame
Day 1 to Day 94
Area under the concentration-time curve from time zero to last time of quantifiable concentration [AUC(last)]
The AUC(last) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Time frame
Day 1 to Day 9Secondary outcomes
1
Safety evaluation endpoints
Incidence of treatment-related adverse events, abnormalities in clinical laboratory, vital signs and electrocardiogram (ECG) as assessed by CTCAE v5.0. According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed.
Time frame
Day1-Day21Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ascentage Pharma Group Inc.
Lead sponsor
Guangzhou Healthquest Pharma Co., Ltd
Collaborator
Source ClinicalTrials.gov