GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers (NCT05814926) | Clinical Trial Compass
CompletedPhase 1
GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
China24 participantsStarted 2023-04-26
Plain-language summary
The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control group with normal hepatic function following oral administration of GP681 as single dose.
Who can participate
Age range18 Years – 68 Years
SexALL
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Inclusion criteria
✓. Male or female participants，between the ages of 18 and 68 years of age (inclusive) at the time of Screening;
✓. Body weight ≥50 kg for males, ≥45kg for females, and body mass index (BMI) between18-30 kg/m\^2(inclusive);
✓. Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.
✓. Healthy participants, between the ages of 18 and 68 years of age (inclusive) at the time of Screening, matched to participants with hepatic impairment with regard to age (+/-10 years), and gender(+/-1 subject);
✓. Body weight ≥50 kg for males, ≥45kg for females, and body mass index (BMI) between18-30 kg/m\^2(inclusive), matched to participants with hepatic impairment with regard to body weight (+/-25% kg);
✓. In good health, determined by no clinically significant findings from vital signs, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory evaluations, and other safety examinations at screening, as assessed by the investigator.
✓. Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 3 months after the final dose of study drug
✓. Adequate hepatic function within 14 days before drug administration defined as: AST or ALT ≤ 1.5 times the upper limit of normal values, total bilirubin within normal limits.
Exclusion criteria
✕. History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to drugs. Those who cannot follow a uniform diet for special dietary requirements.
What they're measuring
1
Peak plasma concentration (Cmax) of the analyte in plasma after oral administration of GP681
Timeframe: Day 1 to Day12
2
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after oral administration of GP681
Timeframe: Day 1 to Day12
3
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration of GP681
✕. History of seizure，including any febrile seizure, or transient ischemic attack, or any condition that may pre-dispose to seizure (such as prior stroke, brain arteriovenous malformation, brain trauma with requiring hospitalization, and lacunar cerebral infarction).
✕. Have a malignant tumor or a history of malignant tumor in the 5 years prior to screening (except for patients with non-melanoma skin cancers with no evidence of recurrence, or patients with excised cervical intraepithelial neoplasia).
✕. Subjects with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
✕. Abnormal blood pressure response, or clinically significant abnormal blood pressure assessed by the investigator.
✕. Having a history of clinically significant ECG abnormalities (history of tachycardia/bradycardia requiring medical therapy, II-III degree atrioventricular block, or QTcF\>450ms for males，\>460ms for females(corrected by Fridericia's formula), or other clinically significant abnormals assessed by the investigator.
✕. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2, according to the modification of diet in renal disease equation.
✕. Those who plan to undergo surgery, or intent to intent to be hospitalized during the trial.