Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects

Exclusion Criteria

• •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neuropsychiatric disease, or any condition that may affect drug absorption, distribution, metabolism, and excretion;
• •Had a severe infection, trauma or major surgery within 4 weeks of screening and at Check-In; plan to have a surgery during the trial;
• •A past medical history of ECG abnormalities, documented cardiac arrhythmias, or cardiovascular disease; or QTcF interval \>450 msec for males, \>470 msec for females, or \<300 msec;
• •Subject's systolic blood pressure (SBP) is \>140 or \<90 mmHg, diastolic blood pressure (DBP) is \>90 or \<50 mmHg, resting heart rate \<40 or \>100 bpm, and respiratory rate \<10 or \>20 breaths/min at Screening or Check-in after resting in a semi-supine position for 5 minutes. Vitals can be repeated twice (a minimum of 1 to 2 minutes apart) based on the investigator's judgment;
• •History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (eg, hepatitis B or C);
• •Subject has a history of type 1 hypersensitivity to any medication;
• •Subject has evidence of substance abuse, a history of substance abuse, or is positive for drugs of abuse (eg, methamphetamines, opiates, methadone, cocaine, amphetamines, cannabinoids, tricyclic antidepressants, phencyclidine, barbiturates, benzodiazepines), or alcohol at Screening and Check-in (Day -1);
• •History of symptomatic hypoglycemia;
• •Subjects who smoke more than 5 cigarettes per day or will not refrain from smoking starting from at least 48 hours prior to screening and check-in on Day -1, and during the study;
• •History of regular alcohol consumption in the past 3 months exceeding an average weekly intake of 14 standard drinks; 1 drink=5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor;
• •Subject has used prescription medications within 14 days or, as per PI discretion, over-the-counter medications, dietary/nutritional supplements (except hormonal contraceptives, paracetamol under 2 grams/day, vitamin supplements) within 7 days or 5 half-lives prior to fluzoparib administration;
• •Treatment with any investigational drug within 3 months (or 5 half-lives, whichever is longer) of dosing;
• •Use of medications affecting liver metabolism within 1 month of screening;
• •Blood donation or loss of more than 200 mL of blood within 1 month of screening; or blood donation or loss of more than 400 mL of blood within 3 months of screening; or received blood within 8 weeks of screening;
• •Any other major illness/condition that, in the investigator's judgment, substantially increased the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.